Aequalis Pyrocarbon Humeral Head IDE Study
Conditions: Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
Sponsor: Stryker Trauma and Extremities

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Pyrocarbon IDE Study 
Protocol #: 15A-T-PYC-R 
IDE#: G140202 
 
 
 
 
Clinical Investigational Plan 
 
 
 
 
 
 
Version: 6 
Date:  Final – January 6, 2017 
 
Sponsor 
Tornier, Inc. 
10801 Nesbitt Ave South 
Bloomington, MN  55437 USA 
Phone:  952-921-7600 
Fax:  952-291-7601 
 
 
 
 
 
 
 
Confidential Information 
No use or disclosure of information contained within 
this document is permitted without prior written authorization from Tornier. 
 

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Signature page 
 

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Synopsis 
Sponsor 
Tornier, Inc. 
Study Title 
Pyrocarbon IDE Study 
Device Name 
AequalisTM Pyrocarbon Humeral Head 
Associated Devices 
The Aequalis Pyrocarbon Humeral Head is used in combination with the 
AequalisTM AscendTM Flex Shoulder System.   
Intended and 
Indications for Use 
This system is intended to be used to partially replace the shoulder joint in 
primary treatment. 
The Aequalis Pyrocarbon Humeral Head associated with the Aequalis Ascend 
Flex stem is indicated for use as a replacement of deficient humeral head joints 
disabled by: 
 
Non-inflammatory degenerative joint diseases (osteoarthritis, avascular 
necrosis) 
 
Traumatic arthritis, 
The Aequalis Pyrocarbon Humeral Head shoulder prosthesis combined with the 
Aequalis Ascend Flex stem, are to be used only in patients with an intact or 
reconstructable rotator cuff and if the native glenoid surface is intact or 
sufficient, where they are intended to increase mobility, stability, and relieve 
pain.  
Study Purpose 
The purpose of this study is to demonstrate safety and effectiveness of the 
Aequalis Pyrocarbon Humeral Head in hemiarthroplasty at 24 months.  Subject 
outcomes will be compared against a performance goal. 
Type of Study 
Prospective, single arm, multi-center 
Primary Composite 
Endpoint 
The primary endpoint is the rate of patient success at 24 months.  A subject is a 
success at 24 months if: 
 
Their change in Constant score is ≥17 and 
 
They did not have revision surgery; and  
 
There is no radiographic evidence of system disassembly or fracture, and 
 
They did not have a system-related serious adverse event. 
Subjects that undergo revision surgery will be considered a primary endpoint 
failure at the time any component of the system is revised. 
Secondary 
Endpoints 
The following data will be tested to detect a significant change at 24 months 
compared to baseline: 
 
Constant score and Adjusted Constant score 
 
American Shoulder and Elbow Surgeons (ASES) Score 
 
Single Assessment Numeric Evaluation (SANE) 
 
EQ-5D 
 
Pain measured by a visual analog scale (VAS) 
 
Range of Motion (ROM) 
 
Strength 
The following data will be summarized: 
 
Adverse events 
 
Revision rate 
 
Level of satisfaction with the shoulder 
 
X-ray data: glenohumeral joint space width, glenoid osteophytes, 
glenoid morphology, glenoid erosion, humeral component radiolucency, 
osteolysis, migration, subsidence, subluxation, acromiohumeral distance, 
anatomic fracture, and additional observations 

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Statistical 
Considerations 
Statistical considerations for the primary endpoint: 
 
The study is designed to test non-inferiority of the composite success endpoint to 
a performance goal derived from the Tornier Aequalis Post-Market Outcomes 
Study.   
 
 
80% power with a one-sided 0.025 level of significance 
 
Non-inferiority test of one proportion  
 
10% non-inferiority margin and performance goal of 85% 
 
Assumed  success rate of 85% 
 
Attrition rate of 15% 
 
The resultant sample size under these assumptions is 133 subjects with an 
implant attempt and evaluable endpoint data.  With 15% attrition, 157 total 
implant attempts are needed. Up to 190 subjects may be enrolled to account for 
pre and intra-operative screen failures.  Enrollment will stop once 157 subjects 
have had an implant attempt. 
 
Statistical considerations for secondary objectives: 
The overall type I error for the powered secondary endpoints will be controlled 
using the Hochberg method for adjusting for multiple comparisons, and will be 
tested only if the primary endpoints are met.    
Enrollment Method 
Subjects are recruited from the patient population within the medical practice of 
the clinical investigators. 
Inclusion Criteria 
A subject must meet all of the following inclusion criteria in order to enter the 
study: 
 
Adult subject 22 years or older. 
 
Scapula and proximal humerus must have reached skeletal maturity. 
 
Clinical indication for hemiarthroplasty due to primary diagnosis of 
arthritis or avascular necrosis.  Primary arthritis for this study includes 
osteoarthritis with pain and/or post-traumatic arthritis. 
 
Willing and able to comply with the protocol. 
 
Willing and able to sign the informed consent form (or the Legally 
Authorized Representative will sign for the subject). 
Exclusion Criteria 
A subject will not be eligible to participate in the study if any of the following 
conditions are present: 
 
Active local or systemic infection, sepsis, or osteomyelitis. 
 
In the opinion of the clinician, there is insufficient bone stock to support 
implants in the humeral metaphysis or poor bone quality. 
 
In the opinion of the clinician, there is insufficient bone stock or 
excessive deformation of the native glenoid to allow normal functioning 
of the glenohumeral joint. 
 
In the clinician’s opinion, the subject is unwilling or unable to be 
compliant with the recommendations of the healthcare professional. 
 
Metabolism disorders that could compromise bone formation, or 
Osteomalacia. 
 
Infection at or near the implant site, distant foci of infections that could 
spread to the site of the implant, or systemic infection. 
 
Rapid destruction of the joint, marked bone loss, or bone resorption 
apparent on X-ray. 

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 
Known allergy or suspected allergy to implant materials. 
 
Female subjects who are pregnant or planning to become pregnant 
within the study period. 
 
Medical conditions or balance impairments that could lead to falls. 
 
Prior arthroplasty or prior failed rotator cuff repair on the affected 
shoulder; (successful rotator cuff surgery may be included). 
 
A rotator cuff that is not intact and cannot be reconstructed.  Subjects 
with a massive rotator cuff tear (>5cm) will be excluded. 
 
Nonfunctional deltoid muscle. 
 
Neuromuscular compromise condition of the shoulder (e.g., neuropathic 
joints or brachial plexus injury with a flail shoulder joint). 
 
Known active metastatic or neoplastic diseases, Paget’s disease, or 
Charcot’s disease. 
 
Currently, within the last 6 months, or planning to be on chemotherapy 
or radiation. 
 
Known alcohol or drug abuse as defined by DSM-5. 
 
Taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, 
within 3 months prior to surgery. 
 
Currently enrolled in any clinical research study that might interfere with 
the current study endpoints. 
 
Known history of renal or hepatic disease/insufficiency.   
 
Anatomy cannot be replicated using current available system sizes. 
Visit Schedule 
Subjects will be assessed at: 
 
Baseline 
 
Surgery 
 
Post-op (1-3 weeks) 
 
3 months 
 
6 months  
 
12 months 
 
24 months 
 
Annual visits after 24 months, if needed 
Duration of 
Investigation 
The study duration is expected to be approximately 4 years, including 18 months 
of enrollment and 24 months of follow-up.   
Number of Patients 
and Sites 
Up to 190 subjects enrolled at up to 20 sites to ensure 157 implant attempts. 
Sponsor Contact Information 
Josh Myers, MS, CRCP 
Clinical Operations Manager 
10801 Nesbitt Ave South 
Bloomington, MN 55437 USAA 
Phone: 952-921-7119 
Fax: 952-487-3677 
Email: josh.myers@wright.com 
 
 

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Contents 
Signature page ............................................................................................................................................... 2 
Synopsis ........................................................................................................................................................ 3 
1 
Definitions and Acronyms .................................................................................................................. 10 
2 
Introduction ......................................................................................................................................... 13 
2.1 
Study Purpose ............................................................................................................................. 13 
2.2 
Study Scope ................................................................................................................................ 13 
2.3 
Governing Regulations ............................................................................................................... 13 
3 
Background and Justification .............................................................................................................. 14 
4 
System Description, Indications, and Intended Use ............................................................................ 15 
4.1 
Investigational Device:  Pyrocarbon Humeral Head ................................................................... 15 
4.1.1 
Aequalis Ascend Flex Stem ................................................................................................ 16 
4.1.2 
Instruments .......................................................................................................................... 17 
4.2 
Indications and Intended Use ...................................................................................................... 17 
4.3 
Surgical Procedure ...................................................................................................................... 18 
5 
Methodology ....................................................................................................................................... 20 
5.1 
Primary Endpoint ........................................................................................................................ 20 
5.2 
Secondary Endpoints................................................................................................................... 20 
5.3 
Subject Selection ......................................................................................................................... 20 
5.3.1 
Inclusion Criteria................................................................................................................. 21 
5.3.2 
Exclusion Criteria ............................................................................................................... 21 
5.4 
Minimization of Bias .................................................................................................................. 22 
6 
Study Site Information ........................................................................................................................ 22 
6.1 
Agreements ................................................................................................................................. 22 
6.2 
Institutional Review Board (IRB) ............................................................................................... 23 
6.3 
Investigator Responsibilities ....................................................................................................... 23 
6.4 
Study Training ............................................................................................................................ 24 
6.5 
Site Activation ............................................................................................................................ 24 
6.6 
Access to Study Records ............................................................................................................. 25 
7 
Study Procedures ................................................................................................................................ 25 
7.1 
Overview of Study Design .......................................................................................................... 25 
7.2 
Informed Consent Process .......................................................................................................... 28 
7.3 
Description of Study Procedures ................................................................................................. 29 

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7.4 
Data Collection ........................................................................................................................... 31 
7.5 
Subject Follow-up Schedule ....................................................................................................... 32 
7.6 
Required Study Visits ................................................................................................................. 32 
7.6.1 
Baseline Visit ...................................................................................................................... 32 
7.6.2 
Day of Surgery .................................................................................................................... 33 
7.6.3 
Rehabilitation Guidelines .................................................................................................... 33 
7.6.4 
Post-op Follow-up ............................................................................................................... 34 
7.6.5 
Follow-up:  3 Months and 6 Months ................................................................................... 34 
7.6.6 
Follow-up:  Annual ............................................................................................................. 35 
7.6.7 
Follow-up: Pre-Operative Screen Failures .......................................................................... 35 
7.6.8 
Follow-up: Intra-Operative Screen Failures ........................................................................ 35 
7.6.9 
Follow-up: Unsuccessful Implant Attempt ......................................................................... 35 
7.6.10 
Follow-up: Revisions .......................................................................................................... 35 
7.6.11 
Follow-up: Explants ............................................................................................................ 35 
7.7 
Additional Data Collection ......................................................................................................... 35 
7.8 
Study Exit .................................................................................................................................... 36 
8 
Investigational Device Handling and Traceability .............................................................................. 37 
9 
Study Deviations ................................................................................................................................. 37 
10 
Adverse Events ............................................................................................................................... 37 
10.1 
Adverse Event Assessment Process ............................................................................................ 37 
10.2 
Adverse Event Definitions .......................................................................................................... 38 
10.3 
Adverse Event Reporting ............................................................................................................ 40 
10.4 
Adverse Event Review ................................................................................................................ 40 
11 
Risk Analysis .................................................................................................................................. 40 
11.1 
Potential Risks ............................................................................................................................ 40 
11.2 
Risk Minimization ...................................................................................................................... 41 
11.3 
Potential Benefits ........................................................................................................................ 41 
12 
Planned Study Closure, Early Termination of Study or Study Suspension .................................... 41 
12.1 
Planned Study Closure ................................................................................................................ 41 
12.2 
Early Termination or Suspension ................................................................................................ 41 
13 
Statistical Methods and Data Analysis ............................................................................................ 42 
13.1 
General Methods ......................................................................................................................... 42 
13.2 
Primary Endpoint ........................................................................................................................ 43 

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13.2.1 
Hypothesis Test ................................................................................................................... 43 
13.2.2 
Sample Size ......................................................................................................................... 44 
13.2.3 
Analysis ............................................................................................................................... 44 
13.2.4 
Missing Data ....................................................................................................................... 44 
13.3 
Secondary Endpoints................................................................................................................... 44 
13.3.1 
Inferential Secondary Endpoints ......................................................................................... 44 
13.3.2 
Additional Secondary Endpoints ........................................................................................ 45 
13.4 
Baseline Assessment ................................................................................................................... 45 
13.5 
Comparability to Aequalis Dataset ............................................................................................. 46 
13.6 
Poolability ................................................................................................................................... 46 
14 
Data and Quality Management ....................................................................................................... 46 
15 
Monitoring, Auditing, and Inspecting ............................................................................................. 47 
15.1 
Monitoring Plan .......................................................................................................................... 47 
15.2 
Audits .......................................................................................................................................... 47 
16 
Medicare Study Criteria .................................................................................................................. 47 
17 
Required Records and Reports ........................................................................................................ 48 
17.1 
Investigator Records ................................................................................................................... 48 
17.2 
Investigator Reports .................................................................................................................... 49 
17.3 
Sponsor Records ......................................................................................................................... 50 
17.4 
Sponsor Reports .......................................................................................................................... 50 
18 
Publications ..................................................................................................................................... 51 
 
Appendix 1  References .............................................................................................................................. 52 
Appendix 2  Strength Testing Protocol ....................................................................................................... 54 
Appendix 3  Subject Rehabilitation Guidelines .......................................................................................... 55 
Appendix 4  System Retrieval and Analysis Protocol ................................................................................ 57 
 
Table 1:  Average Elasticity by Material Type ........................................................................................... 14 
Table 2:  Sizes of Pyrocarbon Humeral Heads ........................................................................................... 16 
Table 3:  Data Collection Overview ........................................................................................................... 31 
Table 4:  Visit Windows ............................................................................................................................. 32 
Table 5:  Adverse Event Reporting Requirements ...................................................................................... 40 
Table 6:  Investigator Reporting Requirements .......................................................................................... 49 
Table 7:  Sponsor Reporting Requirements ................................................................................................ 50 
 
 

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Figure 1:  Pyrocarbon HH Components Pre-Assembly .............................................................................. 15 
Figure 2:  Pyrocarbon HH After Assembly ................................................................................................ 15 
Figure 3:  Cross Section of the Pyrocarbon bearing surface ....................................................................... 16 
Figure 4:  Pyrocarbon HH with Ascend Flex stems .................................................................................... 17 
Figure 5:  Study Overview .......................................................................................................................... 27 
Figure 6: Fixed Force Gauge ...................................................................................................................... 54 
Figure 7: Fixed Force Gauge ...................................................................................................................... 54 
 
 
 
 

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1 Definitions and Acronyms 
 
Term or Acronym 
Definition 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs in subjects, users or other persons, whether or not related to the 
investigational medical device.   
ASAP 
As soon as possible 
ASES  
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment.  
The original ASES consists of 2 portions, a medical professional assessment 
section and a patient self-report section.  The patient self-report section utilized 
in this study is a condition specific scale intended to measure functional 
limitations and pain of the shoulder.  The assessment takes approximately 5 
minutes to complete and consists of 2 dimensions: pain and activities of daily 
living.  The pain score is calculated from the single pain question and the 
function score from the sum of the 10 questions addressing function.  The pain 
score and function composite score are weighted equally (50 points each) and 
combined for a total score out of a possible 100 points [1].   
CIP 
Clinical Investigational Plan 
CoCr 
Cobalt Chromium 
(Adjusted) Constant 
score 
In this score, 35 points are allocated for subjective assessments of pain and 
activities of daily living and 65 points are available for objective measures of 
range of movement and shoulder strength.  A young healthy patient can 
therefore have a maximum score of 100 points [2].   
 
Adjusted Constant Score: The strength of each subject’s normal shoulder may 
differ because gender and age differences.  The Constant score calculation will 
be adjusted using normative values for the Constant score based on age and 
gender [3].   
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
Device Related 
Adverse Event 
An adverse event that results from the presence or performance of the device. 
DOS 
Day of Surgery 
Fixed Force Gauge 
A fixed force gauge is a device for measuring force, moment of force (torque), 
or power.  They are used in shoulder orthopedics for measuring the arm 
strength of patients in order to evaluate physical status, performance and task 
demands.  
eCRFs 
Electronic Case Report Forms 
EDC 
Electronic Data Capture  
EQ5D 
EQ-5D™ is a standardized instrument for use as a measure of health outcome.  
1 
FCI 
Functional Comorbidity Index if a self-administered, general population index 
of comorbid diseases with physical function as the outcome of interest [4] 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HA 
Hemiarthroplasty 
                                                     
 
1 © EuroQol Research Foundation. EQ-5D™ is a trade mark of the EuroQol Research Foundation 

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HH 
Humeral Head 
IA 
Investigator Agreement is a signed agreement documenting his or her 
commitment to conduct the investigation in accordance with this Clinical 
Investigational Plan, all applicable regulations, and any conditions imposed by 
the IRB. 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
ICMJE 
The International Committee of Medical Journal Editors 
IFU 
Instructions For Use 
Institution Review 
Board (IRB) 
An independent body constituted of medical, scientific, and non-scientific 
members, whose responsibility is to ensure the protection of the rights, safety, 
and well-being of human subjects involved in a trial by, among other things, 
reviewing, approving, and providing continuing review of trial protocol and 
amendments and of the methods and material to be used in obtaining and 
documenting informed consent of the trial subjects.  
ITT  
Intent-to-treat  
“Must”, “Required”, 
“Shall” 
These words mean that the definition is an absolute requirement of the 
protocol. 
“Must Not”, “Shall 
Not” 
These phrases mean that the definition is an absolute prohibition of the 
protocol. 
PI 
Principal Investigator 
PP  
Per protocol 
Procedure Related 
Adverse Event 
An adverse event that occurs as a result of the implant procedure.   
 
PyC 
Pyrocarbon 
ROM 
Range of Motion 
Serious Adverse Event 
(SAE) 
An adverse event is serious when it: 
• 
Led to death, 
• 
Led to serious deterioration in the health of the subject, that either 
resulted in 
o A life threatening illness or injury, or 
o A permanent impairment of a body structure or a body 
function, or 
o In-patient or prolonged hospitalization, or  
o Medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body structure 
or a body function, 
• 
Led to fetal distress, fetal death or a congenital abnormality or birth 
defect. 
“Should”, 
“Recommended” 
These words mean that there may exist valid reasons in particular 
circumstances to ignore a particular item, but the full implications must be 
understood and carefully weighted before choosing a different course.   
“Should Not”, “Not 
Recommended” 
These phrases mean that there may exist valid reasons in particular 
circumstances when the particular behavior is acceptable or even useful, but 
the full implications should be understood and the case carefully weighed 
before implementing any behavior described with this label. 
Single Assessment 
Numeric Evaluation 
(SANE) Score 
The SANE rating is determined by the subject’s written response to the 
following question “How would you rate your shoulder today as a percentage 
of normal (0% to 100% scale with 100% being normal)?” 

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Sponsor 
An individual, company, institution, or organization which takes responsibility 
for the initiation, management, and/or financing of a clinical trial. 
Sub-I 
Sub-Investigator 
Subject 
An individual who participates in a clinical trial, either as a recipient of the 
investigational product(s) or as a control. 
Subject Satisfaction 
Subject satisfaction will be measured by asking each subject a single 
subjective question at baseline and each subsequent follow-up visit. Subjects 
will be asked “How satisfied are you with your shoulder?” Response options 
include: “Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied”. 
TSA 
Total Shoulder Arthroplasty 
Unanticipated Adverse 
Device Effect (UADE) 
 
Any serious adverse effect on health or safety, any life-threatening problem or 
death caused by, or associated with a device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the 
study protocol or informed consent; or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects.   
Unavoidable Adverse 
Event 
Those that are expected to occur and inherent with the surgical procedure.  
These only need to be reported if they are deemed by the investigator to be 
more serious in duration or intensity than expected.  Unavoidable AEs include: 
• 
Anesthesia related nausea/vomiting 
• 
Low-grade fever for ~48 hours post-op 
• 
Incisional pain for ~72 hours post-op 
• 
Mild to moderate bruising or hematoma for ~ one week post-op 
• 
Sleep problems (insomnia) for ~ 72 hours post-op 
• 
Back pain related to lying on table 
• 
Normal incision redness 
US 
United States of America 
VAS 
Visual Analog Scale 
Walch Glenoid 
Morphology 
Classification 
A classification of glenoid morphology in OA: 
Type A: Humeral head centered 
• 
A.1 – minor erosion 
• 
A.2 – major erosion 
Type B: Humeral head subluxed posteriorly 
• 
B.1- posterior joint space narrow, subchondral sclerosis, and 
osteophytes 
• 
B.2- Retroverted glenoid with posterior rim erosion 
Type C: Glenoid retroversion > 25 degrees regardless of erosion 
Modified Favard 
Glenoid Erosion 
Classification 
Classification of glenoid erosion.  The modified classification includes a fifth 
classification when glenoid erosion is predominantly located at the inferior 
part of the glenoid. 
 
 
 
 

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2 Introduction 
2.1 Study Purpose 
Tornier, Inc., (Sponsor) is sponsoring the Pyrocarbon IDE Study, a multi-center, prospective, single arm, 
and investigational clinical study.  The purpose of this clinical study is to evaluate the safety and efficacy 
of the Aequalis™ Pyrocarbon Humeral Head (Pyrocarbon HH).  The data generated by this study are 
intended to provide adequate safety and effectiveness information necessary to support a Food and Drug 
Administration (FDA) submission for device clearance.  Data from this clinical study may be used to 
support future regulatory submissions, including those outside of the United States (US).  
2.2 Study Scope 
The study will be conducted at up to 20 sites in the US.  Each participating site will be encouraged to 
enroll approximately 5 subjects in a 12 month time period, or until the implant attempt limit is met 
(N=157). 
Up to 190 subjects will be enrolled to ensure 157 implant attempts with a Pyrocarbon HH to further 
ensure at least 133 evaluable subjects are available for the primary endpoint analysis.  It is anticipated that 
this study will require approximately 24 months for subject enrollment.  To ensure data are adequately 
distributed among sites and geographies, no more than 20% (n=31) of implant attempts may occur at a 
single site.  Each site should attempt to implant approximately 5 subjects within 12 months of activation.  
There is no minimum requirement for enrollments per site. 
Subjects who have a successful implant attempt will be followed for at least 24 months.  Unsuccessful 
implant attempt and screen failure follow-up is outlined in section 7.1.  Study duration (first site 
activation to final subject follow-up) is expected to be approximately 4 years.  Subjects will be followed 
annually after their 24 month visit until the last subject with an implant attempt completes their 24 month 
visit or is determined lost to follow-up; all subject follow-up will be complete at that time.  If deemed 
necessary, subjects may be asked to return for additional visits beyond their final protocol visit to collect 
long-term data.    
2.3 Governing Regulations 
The Pyrocarbon HH is classified as a significant risk investigational device in the US.  This Clinical 
Investigational Plan (CIP) will be submitted to the FDA for approval under an Investigational Device 
Exemption (IDE) and is subject to 21CFR812.  This study will be conducted according to this Clinical 
Investigational Plan (CIP) and in accordance with 21 CFR Parts 50 and 56 concerning medical research.  
The following guidance documents and regulations were consulted in preparing the study’s protocol and 
procedures. 
 
Title 21 of the Code of Federal Regulations (21 CFR) Parts 11 (Electronic Records; Electronic 
Signatures), 50 (Protection of Human Subjects), 56 (Institutional Review Boards), and 812 
(Investigational Device Exemption).   
 
International Conference on Harmonization (ICH) E6 Good Clinical Practice (GCP) guidelines 
 

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3 Background and Justification 
Dr. Charles Neer introduced shoulder arthroplasty for the treatment of displaced fractures of the proximal 
humerus in 1955 [5].  Dr. Neer later modified his prosthesis to treat the degenerative humeral head [6].  
Shoulder arthroplasty has evolved into a viable option for patients with non-inflammatory degenerative 
joint diseases, rheumatoid arthritis, trauma, and correction of functional deformities.  Shoulder 
replacement is effective at restoring range of motion and strength, as well as decreasing pain.  It can also 
help patients return to normal daily activities that were previously limited by the shoulder disease [7] [8] 
[9].  Anatomic shoulder arthroplasty can be done in two different configurations:  Total shoulder 
arthroplasty (TSA) and hemiarthroplasty (HA).  TSA includes artificial components on both the humeral 
and glenoid sides of the glenohumeral joint, while hemiarthroplasty only involves the humeral side. 
The Tornier Aequalis Ascend Flex System is a shoulder arthroplasty system that is currently available on 
the market. Typical anatomic implantation of this system includes the Ascend Flex Stem, and a cobalt 
chrome (CoCr) or Titanium (Ti) humeral heads.  The Investigational component of this study is a 
Pyrocarbon HH which is intended to be used with the stems from the Ascend Flex system, and, while the 
Ascend Flex/ HH system is indicated for both TSA and hemiarthroplasty, the Ascend Flex/ Pyrocarbon 
HH System is only indicated for primary hemiarthroplasty.  
The technological characteristics of the traditional CoCr HH and the Investigational Pyrocarbon HH are 
similar. The two systems have similar articulating geometry and have identical head to stem tapers.  The 
significant difference between the devices is the material composition of the bearing surface being either 
Pyrocarbon composite or traditional CoCr.  In both systems, the head is assembled onto the stem by the 
surgeon during implantation. The Ascend Flex stems used in both systems are identical. 
Pyrocarbon has a unique biomechanical profile of wear resistance and biocompatibility when compared to 
metals such as titanium and CoCr that are typically utilized for manufacture of replacement humeral 
heads.  In comparison to these materials, pyrocarbon has a lower coefficient of friction and modulus of 
elasticity making it more similar to bone.  Pyrocarbon’s elastic modulus is similar to cortical bone and is 
intended to reduce subsidence and bone loss (Table 1, [10]), and allow a more even distribution of forces 
in the implant and the surrounding bones. 
While pyrocarbon has not been previously cleared in the US for articulation against cartilage in the 
shoulder, this articulating couple has been cleared in other orthopedic indications, including the hand and 
foot.  Literature supports the advantages of using pyrocarbon to articulate against native cartilage and 
bone.  It has been shown to have high strength and good resistance to fatigue [11].  Pyrocarbon is highly 
wear resistant when in contact with bone and cartilage, and is intended to reduce wear and inflammation.  
[12] [13] [14].  Wear testing shows that pyrocarbon demonstrates up to 300 times less wear on bone than 
zirconia and medical grade metals [15] [16]. 
Table 1:  Average Elasticity by Material Type 
 
Silicon 
Polyethylene 
Bone 
Pyrocarbon 
Ta6V 
CoCr 
Al2o3 
Young 
Modulus 
GPa 
0.004 
1 
15-20 
20-25 
110 
200-240 
407 
 
 

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4 System Description, Indications, and Intended Use 
4.1 Investigational Device:  Pyrocarbon Humeral Head 
The Pyrocarbon HH is composed of two parts: 
 
A pyrocarbon bearing surface 
 
A double-taper neck made of CoCr 
Both parts are permanently assembled together in Tornier’s cleanroom before packaging and sterilization. 
They are provided to the user as a single assembly, not as modular components.  Testing has been 
performed to evaluate the strength of the assembly during manufacturing, demonstrating that the 
components cannot be disassembled by the user. 
Figure 1:  Pyrocarbon HH Components Pre-Assembly 
 
Figure 2:  Pyrocarbon HH After Assembly 
 
The pyrocarbon bearing surface is made of a graphite core (also called substrate) covered with a layer of 
pyrocarbon which completely covers the surface so that the body is not in contact with the graphite. The 
graphite core is made from grade AXF-5Q10W graphite that is impregnated with 10% in weight of 
Tungsten for radio-opacity. 
 
 

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Figure 3:  Cross Section of the Pyrocarbon bearing surface 
                               
 
The Pyrocarbon HH features a male taper compatible with Aequalis Ascend Flex stems.  The head’s 
dimensions (size, eccentricity) are similar to the dimensions of the metallic humeral heads used with the 
traditional Ascend Flex System. The types and sizes of Pyrocarbon HH devices are listed in Table 2.   
Table 2:  Sizes of Pyrocarbon Humeral Heads 
Diameter (mm) 
Height (mm) 
Eccentricity 
(mm) 
Catalog Numbers 
39 
14 
1.5 
DWH039U 
41 
15 
DWH041U 
43 
16 
DWH043U 
46 
17 
DWH046U 
48 
18 
DWH048U 
50 
16 
DWH050U 
52 
19 
DWH052U 
54 
23 
DWH054U 
39 
14 
3.5 
DWH139U 
41 
15 
DWH141U 
43 
16 
DWH143U 
46 
17 
4 
 
DWH146U 
48 
18 
DWH148U 
50 
16 
DWH150U 
52 
19 
DWH152U 
54 
23 
DWH154U 
 
The Pyrocarbon HH is an investigational device.  The investigator will have access to two devices of each 
size during the surgical procedure and will ultimately implant one per subject.  Investigational devices 
will only be used by investigators approved to participate in the clinical study.  Pyrocarbon HH devices 
will be labeled as investigational and device disposition will be tracked.   
4.1.1 Aequalis Ascend Flex Stem 
The Aequalis Ascend Flex System is cleared for use in the US and is not investigational.  When the 
Ascend Flex stem is used with a Pyrocarbon HH in a subject, it becomes an investigational system.  
Ascend Flex stems will be purchased through normal distribution channels.  Shipping and disposition will 
not be tracked prior to implant in a study subject, but will be tracked after implant and if explanted.  
Ascend Flex stems are available press fit or cemented in standard or long lengths, each in a variety of 

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sizes.  All commercially available Ascend Flex stems may be used in the study.  The appropriate stem 
will be used based on physician preference and standard of care. 
Figure 4:  Pyrocarbon HH with Ascend Flex stems 
              
 
4.1.2 Instruments 
Instruments are provided for use during the procedure.  The instruments are described in detail in the 
Surgical Manual (NOTE: The large impactor tip and silicone tips marked for use with head sizes 46, 48, 
and 50 must be used with the large head sizes: 52 and 54).  The standard instrumentation provided for a 
traditional Ascend Flex System implant is also used for a Pyrocarbon HH implant.  The only difference 
between the procedures is that the impaction step must be completed using the Spring Impactor for the 
Pyrocarbon HH, whereas the use of this tool is optional with a traditional Ascend Flex System implant.  
This tool is used during the final implantation step to deliver the exact amount of energy necessary to impact 
the humeral head onto the stem without damaging the pyrocarbon coating. 
4.2 Indications and Intended Use 
This system is intended to be used to partially replace the shoulder joint in primary treatment. 
The Aequalis Pyrocarbon Humeral Head associated with the Aequalis Ascend Flex stem is indicated for 
use as a replacement of deficient humeral head joints disabled by: 
 
Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) 
 
Traumatic arthritis, 
The Aequalis Pyrocarbon Humeral Head shoulder prosthesis combined with the Aequalis Ascend Flex 
stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid 
surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain. 

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4.3 Surgical Procedure 
It is required that implanting physicians have experience with at least 15 cases using the Ascend Flex 
System prior to implanting a Pyrocarbon HH device into a study subject.  This is required so the 
investigator is familiar with the system, which will reduce the risk to study subjects when the system is 
combined with the investigational device. 
The surgical procedure is detailed in the Surgical Manual and summarized below.  The surgical procedure 
is the same as it would be for a traditional Ascend Flex System implant.  Use of the Spring Impactor is 
required for the impaction step.  Some steps in the surgical procedure will be standardized for the study to 
reduce confounding factors. 
1. Positioning:  If the implanting physician elects to use the beach chair position, recent literature 
states patients undergoing shoulder surgery in the beach chair position may be at increased risk 
for serious neurocognitive complications due to cerebral ischemia [17].  
2. Humeral Exposure:  To gain access to the glenohumeral joint and dislocate the humeral head, 
surgeons typically utilize a delto-pectoral approach.  For the purpose of the study, all 
investigators will use the delto-pectoral approach.   
3. Soft-Tissue Dissection:  Long head biceps tenodesis must be performed.  Subscapularis 
resection, transosseous suture, tendon to tendon suture, tendon to bone suture, lesser tuberosity 
fleck osteotomy are all acceptable  
4. Humeral Head Preparation and Resection:  The humeral head is dislocated after the soft-tissue 
dissection is complete.  After dislocation, osteophytes are removed (if necessary) and the humeral 
head is resected (cut) from the humerus.  This may be done either free hand or with the assistance 
of a cutting guide.   
5. Distal Preparation:  The medullary canal is prepared using “Sounders”.  Sounder sizes are 
progressively increased until contact is made with the cortical wall of the canal. 
6. Proximal Preparation:  The opening to the medullary canal is further widened using guided 
punches to score the proximal metaphyseal cancellous bone.  Once the cancellous bone has been 
scored, the Sounder, Punch, and scored bone are removed. 
7. Metaphyseal Compaction:  The compaction tool is advanced into the canal until a satisfactory 
fit is achieved.  The inclination angle is locked so it can be read at a subsequent step.  The 
compactor is temporarily left inside the humerus as the trial implant. 
8. Surface Planning:  With the final compactor in place, a surface planer is utilized to ensure a flat 
resection true to the implant. 
 

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9. Glenoid Treatments, if any:  Glenoids may be prepared by reaming and/or reshaping to remove 
calcified cartilage and irregular surfaces to ensure smooth rotation of the humeral head on the 
glenoid face.  If there is eccentric wear of the glenoid, smoothing, reaming, and/or reshaping of 
the glenoid face is allowed to ensure proper version and balance to the joint. The procedure 
guidelines are as follows: 
The glenoid is exposed. Any remaining cartilage and marginal osteophytes are then 
removed from the glenoid. Reaming may be performed with a motorized bur or reamer.  
If reshaping with a motorized reamer, a starting hole is made at the center of the glenoid 
face to receive the nub of the reamer.  Reaming is conservative, preserving as much bone 
stock as possible. It is continued only until a concentric surface is achieved across the 
entire face of the glenoid. If the glenoid is biconcave with substantial posterior erosion, 
the crest between the two concavities is removed and the glenoid is then reamed until a 
single concavity is achieved.   
Excessive reaming or reshaping that severely compromises the structure of the glenoid surface 
will not be permitted and if excessive reaming or reshaping is performed this will cause the 
subject to be considered an unsuccessful implant attempt. Excessive reaming is defined as an 
amount of reaming that removes excessive bone so that the remaining glenoid will not adequately 
support articulation with the humeral head. This limit will be defined by the operating surgeon. 
The patient would then receive an alternate treatment, e.g., glenoid bone grafting 
in conjunction with use of a conventional hemiarthroplasty or reverse total shoulder prosthesis. 
10. Humeral Head Sizing: The correct Pyrocarbon HH device size will be determined using the trial 
heads.  The humeral head trials are positioned onto the compactor to achieve optimal coverage of 
the resecting and the humeral head trial is reduced into the glenoid.  Mobility testing is performed 
with the trial construct in place.  Once the humeral head size, offset, and rotation have been 
confirmed, the shoulder is dislocated and the trial construct is removed. 
11. Final Stem Implantation:  To avoid repeated impactions onto the Aequalis Pyrocarbon Humeral 
Head, the definitive uncemented stem is first impacted into the humerus. The Aequalis 
Pyrocarbon Humeral Head will then be impacted onto the stem.  If the chosen definitive stem is 
cemented the Pyrocarbon head shall be impacted onto the stem on the back table.  
12. Final head Implantation:  During this step, the Spring Impactor is used to impact the 
Pyrocarbon HH onto the Ascend Flex stem. The elasticity of the Spring Impactor should be tested 
prior to impaction.  Ensure the appropriate silicone tip is well connected to the Spring Impactor 
prior to use.  Hold the Spring Impactor with the handle facing down, the handle should not fall 
under its own weight and should stay in touch at the bottom of the sleeve.  Make sure to visualize 
the contact between the hammer and the bottom of the sleeve via the fluid evacuation holes near 
the tip of the Spring Impactor.  It is necessary to activate and release the Spring Impactor 3 times 
to achieve adequate fixation. The final implant is done in vivo for press-fit stems.  Back table 
assembly is allowed for the cemented stem. 
13. Testing and Closure:  After the joint has been washed and the prosthesis reduced, the stability 
and mobility of the shoulder are tested.  The subscapularis must be repaired, if detached.  The 
joint and wound are closed.  Post-operatively the arm is immobilized in a simple sling. 

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14. Post-Operative Rehabilitation:  Rehabilitation will be standardized for study subjects, and will 
align with Ascend Flex System recommendations from the Surgical Manual  Study specific 
rehabilitation instructions are found in section 7.6.3. 
5 Methodology 
This is a multicenter, prospective, single arm, investigational study designed to evaluate the safety and 
efficacy of the Pyrocarbon HH when used with the Ascend Flex System in the primary replacement of the 
humeral side of the shoulder joint.  
5.1 Primary Endpoint 
The primary endpoint is the rate of patient success at 24 months.  A subject is a success at 24 months if: 
 
Their change in Constant score is ≥17 and 
 
They did not have revision surgery; and  
 
There is no radiographic evidence of system disassembly or fracture, and 
 
They did not have a system-related serious adverse event. 
Subjects that undergo revision surgery will be considered a primary endpoint failure at the time any 
component of the system is revised. 
5.2 Secondary Endpoints 
The following data will be tested to detect a significant change at 24 months compared to baseline: 
 
Constant Score and Adjusted Constant Score 
 
American Shoulder and Elbow Surgeons (ASES) Score 
 
Single Assessment Numeric Evaluation (SANE) 
 
EQ-5D 
 
Pain measured by a visual analog scale (VAS) from the ASES questionnaire  
 
Range of Motion (ROM) 
 
Strength 
 
The following data will be summarized: 
 
Adverse events 
 
Revision rate 
 
Level of satisfaction with the shoulder 
 
X-ray data: glenohumeral joint space width, glenoid osteophytes, glenoid morphology, glenoid 
erosion, humeral component radiolucency, osteolysis, migration, subsidence, subluxation, 
humeral head integrity, acromiohumeral distance, anatomic fracture, and additional observations. 
5.3 Subject Selection 
The study population will be patients seen by the investigators for treatment of shoulder pain. Tornier will 
provide investigators with training on subject recruitment and provide recruitment materials, such as 
brochures, peer to peer letters, and advertisement options, if requested.  All recruitment materials must be 
approved by the institution’s Institutional Review Board (IRB) before use. 
 

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Subjects must consent to participate in the study prior to any study specific procedures being performed to 
determine if the subject is eligible for the study.  Each subject who signs the study Informed Consent 
Form (ICF) will be considered an enrolled subject.  All enrolled subjects will be documented in the 
electronic data capture (eDC) system via electronic Case Report Forms (eCRFs).  Subjects will count 
towards the implant attempt limit of 157 subjects once the inclusion/exclusion criteria are met (including 
both successful and unsuccessful implantation of a PYC HH). 
 
Investigators may only implant one Pyrocarbon HH in one shoulder per subject.  Subjects are not allowed 
to have Pyrocarbon Humeral Heads implanted into both shoulders as a part of this study. 
5.3.1 Inclusion Criteria 
A subject must meet all of the following inclusion criteria in order to enter the study: 
 
Adult subject 22 years or older. 
 
Scapula and proximal humerus must have reached skeletal maturity. 
 
Clinical indication for hemiarthroplasty due to primary diagnosis of arthritis or avascular 
necrosis.  Primary arthritis for this study includes osteoarthritis with pain and/or post-traumatic 
arthritis. 
 
Willing and able to comply with the protocol. 
 
Willing and able to sign the informed consent form (or the Legally Authorized Representative 
will sign for the subject). 
5.3.2 Exclusion Criteria 
A subject will not be eligible to participate in the study if any of the following conditions are present: 
 
Active local or systemic infection, sepsis, or osteomyelitis. 
 
In the opinion of the clinician, there is insufficient bone stock to support implants in the humeral 
metaphysis or poor bone quality. 
 
In the opinion of the clinician, there is insufficient bone stock or excessive deformation of the 
native glenoid to allow normal functioning of the glenohumeral joint. 
 
In the clinician’s opinion, the subject is unwilling or unable to be compliant with the 
recommendations of the healthcare professional. 
 
Metabolism disorders that could compromise bone formation, or Osteomalacia. 
 
Infection at or near the implant site, distant foci of infections that could spread to the site of the 
implant, or systemic infection. 
 
Rapid destruction of the joint, marked bone loss, or bone resorption apparent on X-ray. 
 
Known allergy or suspected allergy to implant materials. 
 
Female subjects who are pregnant or planning to become pregnant within the study period. 
 
Medical conditions or balance impairments that could lead to falls. 
 
Prior arthroplasty or prior failed rotator cuff repair on the affected shoulder; (successful rotator 
cuff surgery may be included). 
 
A rotator cuff that is not intact and cannot be reconstructed.  Subjects with a massive rotator cuff 
tear (>5cm) will be excluded. 
 
Nonfunctional deltoid muscle. 

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 
Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus 
injury with a flail shoulder joint). 
 
Known active metastatic or neoplastic diseases, Paget’s disease, or Charcot’s disease. 
 
Currently, within the last 6 months, or planning to be on chemotherapy or radiation. 
 
Known alcohol or drug abuse as defined by DSM-5. 
 
Taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to 
surgery. 
 
Currently enrolled in any clinical research study that might interfere with the current study 
endpoints. 
 
Known history of renal or hepatic disease/insufficiency.   
 
Anatomy cannot be replicated using current available system sizes. 
 
5.4 Minimization of Bias 
Potential sources of bias in this study may result from selection of subjects, treatment of subjects, and 
evaluation of study data. The following methods have been incorporated into the study protocol to 
minimize potential bias: 
 
Patients will be screened to confirm eligibility for enrollment with defined inclusion/exclusion 
criteria prior to implant attempt. 
 
To ensure data are distributed among sites and geographies, the number of successful implants 
per site cannot exceed 20% (n=31) of the total implant attempts. 
 
All sites will use the same version of the CIP and data collection materials. 
 
An independent core lab will perform data analysis for x-rays. 
 
All study and Sponsor personnel will be trained on their respective aspects of the study using 
standardized training materials. 
 
All study personnel will be trained on and required to follow the CIP. 
 
An independent physician consultant, not associated with the study, will regularly review and 
adjudicate reported adverse events. 
 
All study investigators will be required to comply with 21 CFR Part 54, Financial Disclosure by 
Clinical Investigators. 
 
Tornier will monitor the investigation for adherence to GCP the CIP and accurate data reporting. 
6 Study Site Information 
6.1 Agreements 
Tornier will obtain two signed agreements from each participating principal investigator (PI).   
1) Investigator Agreement (IA):  A signed agreement documenting his or her commitment to 
conduct the investigation in accordance with this Clinical Investigational Plan, all applicable 
regulations, and any conditions imposed by the IRB. 
2) Clinical Trial Agreement (CTA):  This is an agreement between Tornier and the PI and/or 
investigative site.  This agreement will outline the financial and contractual arrangements 
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Sub-investigators will sign a Sub-Investigator Acceptance Form, which is an exhibit included in the CTA. 
6.2 Institutional Review Board (IRB) 
IRB approval of the current CIP, ICF, and any other study materials provided to prospective subjects is 
required prior to enrolling any subjects into this study.  Recruitment materials must be approved by the 
IRB prior to their presentation to prospective subjects.  Continuing review is required throughout the 
duration of the study until the time of study closure. 
6.3 Investigator Responsibilities 
The investigator is responsible for understanding and complying with all investigator responsibilities 
described in:  
 
21 CRF 812 Subpart E, Responsibilities of Investigators 
 
Guidance for Industry:  Investigator Responsibilities- Protecting the Rights, Safety, and Welfare 
for Study Subjects 
 
Good Clinical Practices (GCP) Section 4, Investigators.   
The responsibilities described in these documents are summarized below. 
 
The investigator is responsible for ensuring that this study is conducted according to the signed 
agreements, this CIP, all applicable regulations, and any conditions imposed by the IRB.  The 
investigator must document and explain any deviation from this CIP. 
 
The investigator is responsible for ensuring all IRB policies and procedures are followed. 
 
The investigator is responsible for protecting the rights, safety, and welfare of subjects under the 
investigator’s control. 
 
The investigator is responsible for ensuring that informed consent is obtained in accordance with 
21 CFR 50, Protection of Human Subjects. 
 
The investigator is responsible for control of investigational devices in his or her facility and must 
ensure they are only used by authorized persons for subjects in this study, and must ensure they 
are returned to Tornier when requested. 
 
An investigator may determine whether potential subjects would be interested in participating in 
an investigation, but shall not request the written informed consent of any subject to participate, 
and shall not allow any subject to participate before obtaining IRB approval. 
 
An investigator must disclose sufficient accurate financial information to satisfy requirements 
under 21 CFR part 54, Financial Disclosure.  The investigator must promptly update the 
information if any relevant changes occur throughout the study and for one year following study 
closure. 
 
The investigator must maintain a list of appropriately qualified persons to whom the investigator 
has delegated study activities.  This document is referred to as the Delegation of Authority Log 
for this study.  Even though tasks may be delegated, the investigator is ultimately responsible for 
the conduct of the study at his or her institution.  The investigator must not allow persons on the 
delegation log to perform study activities until they are trained by the Tornier study team. 
 
The investigator must have sufficient time and resources to properly conduct and complete the 
study. 

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 
The investigator, or a sub-investigator, must be responsible for all study related medical decisions 
and ensure that adequate medical care is provided to a subject for adverse events.   
 
The investigator should ensure the accuracy, completeness, and timeliness of all data and reports 
submitted to Tornier and the IRB.   
6.4 Study Training 
Persons who conduct study activities under this CIP must be trained prior to performing study activities.   
Principal investigators (PI) and sub-investigators (Sub-I) must be trained on the use of the Ascend Flex 
System.  Implanting investigators must have used the Ascend Flex System in at least 15 cases prior to 
using it with the Pyrocarbon HH in a study subject.  This requirement does not apply to investigators who 
will not perform study surgeries.   
The site PI must be trained before the site may be activated.  PIs will be trained on the following: 
 
The Pyrocarbon HH surgical manual and aspects of the surgery that are required for the study. 
 
CIP, including but not limited to: visit procedures, informed consent, subject recruitment, 
investigator’s responsibilities, investigational device usage and handling, data collection, 
electronic data capture system, adverse events, reporting requirements, subject withdrawal, and 
study deviations. 
 
ICH Guideline on Good Clinical Practices (GCP) E6, Section 4, Investigator 
 
Investigator responsibilities described in 21 CRF 812 Subpart E 
 
Investigators will be trained on the requirement to inform women of child bearing age of the 
unknown risk of harm to the fetus during the informed consent process.     
All other site and sponsor personnel who perform study activities must be trained on study activities 
relevant to their roles and responsibilities.   
6.5 Site Activation 
Site activation is defined as the point in time where the sponsor notifies the PI in writing that the study 
may begin and subjects may be enrolled at his or her site.  All local regulatory requirements must be 
fulfilled before the site can be activated.  Tornier will provide each PI written notification upon site 
activation.  The following must be complete and received by Tornier prior to a site’s activation: 
 
FDA approval of the IDE application 
 
Financial Disclosure Form:  The PI must disclose any financial arrangements he or she has with 
Tornier that meet the following requirements per 21CFR54: 
o Payment to the PI that could be influenced by the outcome of the study. 
o Any significant payments (≥ $25,000) of other sorts, such as research grants, consulting, 
etc. 
o Any proprietary interest in the investigational product 
o Any significant equity interest in Tornier (≥ $25,000) 
 
Study Training for any investigator who is performing implants 
 
IRB approval of the CIP 
 
IRB approved ICF 
 
Current Curriculum Vitae (CV) of the PI 

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 
Fully executed CTA between Tornier and the PI and/or Institution 
 
IA form signed and dated by the PI 
 
Confirmation the implanting physician has completed at least 15 Ascend Flex implants 
Other study site personnel, including sub-investigators, may not participate in study activities until they 
meet all individual requirements.  This may occur at the same time as PI/site activation, or at a later date.   
The following must be completed before individual site personnel may perform study activities: 
 
Site activation must be complete (the PI must have all items above completed) 
 
Training pertinent to the individual’s role 
 
Individuals must be named on the list of appropriately qualified persons to whom the investigator 
has delegated significant study-related duties.   
 
Current Curriculum Vitae (for sub-investigators only) 
 
Sub-investigators must sign the Sub-Investigator Acceptance Form 
 
Financial Disclosure Form (for sub-investigators only) 
6.6 Access to Study Records 
The PI and site personnel must permit study-related monitoring, audits, IRB review and regulatory 
inspections by providing direct access to source documents. The PI should be available to the clinical 
study team to discuss the results of monitoring visits. Access to subject records (including hospital and 
clinic records) and regulatory documents must be granted to the Sponsor’s monitors.   
7 Study Procedures 
7.1 Overview of Study Design 
Figure 5 outlines the study overview and subject flow.  Subjects who are screened and provided informed 
consent are considered enrolled and will complete a pre-operative baseline study assessment.   
Subjects who are enrolled and have a successful implant attempt (implant stable through wound closure) 
will have study assessments at 2 weeks, 3 months, 6 months, 12 months, 24 months, and annually 
thereafter (until the last subject with an implant attempt completes their 24 month visit or is determined 
lost to follow-up) following surgery.  Subjects will exit the study after the last subject with an implant 
attempt completes their 24 month assessment unless it is determined, at the end of the study, to follow 
subjects long-term.  
Subjects who are enrolled and have an unsuccessful implant attempt (attempt to implant the Pyrocarbon 
Humeral Head was not successful during the index procedure) will have annual post-op visits at 12 and 
24 months in order to collect any available safety information.  This also includes subjects who are 
excluded due to excessive glenoid reaming performed with the intent of implanting the Pyrocarbon 
Humeral Head.  Subjects will exit the study after the 24 month assessments are complete. 
Subjects who are enrolled but become screen failures intra-operatively (prior to the implant attempt) will 
have the reason for screen failure documented and then will be followed annually to collect any available 
safety information.  Subjects will exit the study after the 24 month assessments are complete. 

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Subjects who are enrolled but become screen failures pre-operatively (prior to surgical procedure) will 
have the reason for screen failure documented then will be exited from the study.   
If any component of the investigational system is revised, the subject will follow the planned follow-up 
visits.  If any component of the investigational system is permanently explanted during the course of the 
study, the subject will only have annual post-op visits at 12 and 24 month to gather available safety 
information.  Revisions and explants are defined in section 7.7 
 
 

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Figure 5:  Study Overview 

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7.2 Informed Consent Process 
Informed Consent is a legally effective, documented confirmation of a subject’s voluntary agreement to 
participate in a clinical investigation after information has been given to the subject on all aspects of the 
clinical investigation that are relevant to the subject’s decision to participate.  The CIP and ICF will be 
approved by an IRB prior to the commencement of the clinical investigation at an investigative site.  Any 
changes to the ICF must be approved by the IRB reviewing the application before being used to consent a 
prospective study subject.  It is recommended, but not required, that changes made to the ICF be 
submitted to Tornier for review prior to being used to consent a prospective study subject.  The current 
IRB approved version of the ICF must be used.  Subjects must provide informed consent prior to any 
study-related procedures. 
The process of obtaining a patient’s informed consent will: 
 
Ensure that the PI or his/her authorized designee conducts the informed consent process 
 
Include all aspects of the clinical investigation that are relevant to the subject’s decision to 
participate throughout the clinical investigation 
 
Provide opportunity for subject to ask questions  
 
Avoid any coercion or undue improper influence on, or inducement of, the subject to participate 
 
Not waive or appear to waive subject’s legal rights 
 
Use native language that is non-technical and understandable to the subject 
 
Provide ample time for the subject to consider participation 
 
Provide the subject with a copy of the ICF 
 
Ensure important new information is provided to new and existing subjects throughout the 
clinical study 
 
Ensure female subjects of child bearing age understand that the risk of harm to the fetus is 
unknown. 
The original signed and dated ICF must be retained at the investigative site and available for monitoring 
and auditing.  A copy of the signed and dated ICF (and data privacy language where required by law) 
must be provided to the subject (or person who signed the form in the case of a legally authorized 
representative).  Data protection authorization/or other privacy language needs to be collected where 
required by law or local regulation.  If using an electronic ICF, there needs to be a documented electronic 
signature process which is in compliance with applicable regulations (see 21 CRF part 11).  It is 
recommended that the informed consent process is documented in the subject’s medical records.  Any 
new information should be provided to the subject if it could affect the subject’s willingness to 
participate. 
 

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7.3 Description of Study Procedures 
 
Subject Questionnaire  
The subject will complete a questionnaire that has questions about quality of life, daily activities, pain and 
satisfaction with the shoulder.  The answers to the questions are used to calculate the Constant score, Age 
Adjusted Constant Score, ASES, SANE, EQ5D, and subject satisfaction scores.  The questionnaire is in a 
paper format and will include brief instructions. Site personnel who will administer the questionnaire will 
explain the instructions to the subject.  If a subject does not speak English, the questionnaire will either be 
translated, or read to the patient in a language he or she can understand.  Subjects must complete the 
questionnaire on their own unless they are unable to read or write.  In the case where the subject is unable 
to complete the questionnaire on their own, the site personnel may read the questions and answers to the 
subject and document their verbal response.  If this occurs, it must be documented in the subject’s 
medical records. 
The Constant score, Adjusted Constant Score, ASES, SANE, Subject Satisfaction, EQ5D, and FCI 
assessments are described below: 
 
Constant score:  In this score, 35 points are allocated for subjective assessments of pain and 
activities of daily living and 65 points are available for objective measures of range of movement 
and shoulder strength.  A young healthy patient can therefore have a maximum score of 100 
points [2].   
 
Adjusted Constant Score:  The strength of each subject’s normal shoulder may differ because of 
gender and age differences.  The aforementioned Constant score calculation will be adjusted 
using normative values for the Constant score based on age and gender.   
 
ASES:  The original American Shoulder and Elbow Surgeons Score consists of 2 portions; a 
medical professional assessment section and a patient self-report section.  The patient self-report 
section, utilized in this study, is a condition specific scale intended to measure functional 
limitations and pain of the shoulder.  The assessment takes approximately 5 minutes to complete 
and consists of 2 dimensions: pain and activities of daily living.  The pain score is calculated from 
the single pain question and the function score from the sum of the 10 questions addressing 
function.  The pain score and function composite score are weighted equally (50 points each) and 
combined for a total score out of a possible 100 points [1].   
 
SANE:  The Single Assessment Numeric Evaluation rating is determined by the subject’s written 
response to the following question “How would you rate your shoulder today as a percentage of 
normal (0% to 100% scale) with 100% being normal [18].  
 
EQ-5D: a standardized instrument for use as a measure of health outcome. It is cognitively 
simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as 
a single index value for health status. 
 
Subject Satisfaction:  Subject satisfaction will be measured by asking each subject a single 
subjective question. Subjects will be asked “How satisfied are you with your shoulder?” 
Response options include: “very satisfied, satisfied, dissatisfied, and very dissatisfied”. 
 
FCI (Baseline ONLY):  Physical function, health status, and perceived quality of life are 
important indicators, from the patient’s perspective, of the success of medical and surgical 

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interventions.  As a result, condition-specific and generic measures of health are used 
ubiquitously to evaluate medical and surgical interventions.  However, in many types of research 
it is essential to adjust for other diseases, called comorbid diseases, in addition to the disease of 
concern, which may be related to the outcome(s) of interest.  This is of particular importance in 
research conducted in older populations where many chronic illnesses may be present in the same 
patient.  The Functional Comorbidity Index is a self-administered, general population index of 
comorbid diseases with physical function as the outcome of interest.  The underlying premise is 
that diagnoses associated with physical function would be, at least in part, different from those 
associated with mortality, and therefore, an index designed with physical function as the outcome 
would perform better than indices designed with mortality as the outcome of interest.  The FCI 
contains 18 diagnoses scored by adding the number of “yes” answers, with a score of 0, 
indicating no comorbid illness, and a score of 18, indicating the highest number of comorbid 
illnesses.  [4] 
Instability Tests [19] 
 
Sulcus sign:  With the arm straight and relaxed to the side of the subject, the elbow is grasped and 
traction is applied in an inferior direction. With excessive inferior translation, a depression occurs 
just below the acromion. The appearance of this sulcus is a positive sign.   
 
Anterior Drawer Test:  With the subject supine and the shoulder just over the edge of the table, 
the examiner abducts the subject’s arm 60-70˚ with a slight internal rotation.  A slight axial load 
is applied to the arm, the humeral head is translated anteriorly over the glenoid rim, and then the 
degree of anterior translation determined.   
 
Posterior Drawer Test:  With the subject supine and the shoulder just over the edge of the table, 
the examiner abducts the arm 50˚-60˚ and in neutral rotation.  The examiners hand is placed with 
the thumb on the anterior humeral head and the remaining fingers behind the humeral head.  As 
the thumb pushes the humeral head posteriorly, the arm is flexed forward toward the examiner.  
The fingers placed posteriorly can be used to feel the humeral head subluxate over the posterior 
glenoid rim and then the degree of posterior translation determined.   
Range of Motion 
Range of Motion (ROM) is a movement test conducted on a joint to diagnose level of pain and function. 
The shoulder joint has a greater Range of Motion than all other joints in the body, and therefore it is 
important that accurate measurements be obtained to diagnose shoulder health and dysfunction. 
There are various methods to measuring active and passive Range of Motion in the shoulder; visual 
estimation, goniometry, and still photography (among other less common methods).  Each of these 
methods has been shown to offer fair-good levels of accuracy of measurement by an experienced clinician 
or trained measurer.  In this study, ROM will be measured using a goniometer for forward flexion in 
relation to the thorax, abduction, and external rotation (arm at side and arm abducted to 90°) [20].  In 
addition, internal rotation will be measured using anatomical landmarks [2]. 
 
 

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Strength 
The subject’s strength will be assessed using a fixed force gauge.  The fixed force gauge is held in place 
by the examiner and the subject pulls upward with maximum effort for approximately five seconds.  The 
test can be completed up to three times and the maximum score is used, however all three pulls will be 
recorded.  The test is done only on the affected arm.  The result of this test contributes to the adjusted 
Constant score calculation [2] [3].  The strength test is further described in Appendix 2. 
X-Ray 
At least two x-ray views of the shoulder must be taken.  Required views include the external rotation 
Grashey and axillary.  Exceptions will be allowed at the immediate post-op follow-up visit if reasonable 
and necessary.   
X-rays will be submitted to centralized independent reviewers for analysis.  Two independent reviewers 
will analyze each x-ray and a third reviewer will adjudicate discrepancies.  The reviews will be recorded 
electronically in the study database.   
Baseline x-rays will be assessed for acromiohumeral distance, glenohumeral joint space width, glenoid 
osteophytes, glenoid morphology, and glenoid erosion.  Follow-up x-rays will be assessed for the same 
things as well as humeral component radiolucency, osteolysis, migration, subsidence, subluxation, 
integrity, anatomic fracture, and any additional observations. 
Refer to the Imaging Charter for additional information. 
7.4 Data Collection 
The study data that will be collected at each visit is listed in Table 3.  Data will be submitted to Tornier 
via an Electronic Data Capture (EDC) system using electronic Case Report Forms (eCRFs).  Worksheets 
will be provided to investigative sites to aid in data collection during subject visits.  Data should be 
entered into the database in a timely manner.  Queries will be issued via the EDC system as a part of data 
quality assurance and monitoring. 
Table 3:  Data Collection Overview 
*Optional  
 
Baseline 
(Pre-op) 
Day of 
Surgery 
(DOS) 
Post-op 
Follow-up 
(5-21 days) 
Follow-up   
3M 
(69-111 days) 
Follow-up   
6M 
(159-201 days) 
Follow-up 
12M  
(323-407 days) 
Follow-up 
24M 
(688-772 days) 
Follow-up 
Annual 
(if applicable) 
Demographics, 
Medical History and 
Indication 
X 
 
 
 
 
 
 
 
Intraoperative Data 
 
X 
 
 
 
 
 
 
Subject Questionnaire  
X 
 
 
X 
X 
X 
X 
X 
Range of Motion 
X 
 
 
X* 
X* 
X 
X 
X 
Strength Test 
X 
 
 
X* 
X* 
X 
X 
X 
Pain Medications  
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Event 
Assessment 
 
X 
X 
X 
X 
X 
X 
X 
X-ray 
X 
 
X 
 
X 
X 
X 
X 

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7.5 Subject Follow-up Schedule 
Visit windows are provided to allow scheduling flexibility.  Subject follow-up visits or procedures that do 
not occur in the windows listed in Table 4 will be considered a study deviation and require completion of 
a study deviation form.  The day of surgery (DOS) is considered day zero.  The baseline visit is preferred 
to occur as close as possible to the surgery and must be within 60 days prior to surgery. 
Table 4:  Visit Windows 
Study Visit 
Visit Window 
Baseline 
60 days pre-op through DOS 
Post-op Follow-up 
5-21 days post-op 
3 Month Follow-up 
90 Days post-op  ± 21 days 
6 Month Follow-up 
180 Days post-op ± 21 days 
12 Month Follow-up 
365 Days post-op ± 42 days 
24 Month Follow-up 
730 Days post-op ± 42 days 
36 Month Follow-up (if applicable) 
1095 Days post-op ± 84 days 
48 Month Follow-up (if applicable) 
1460 Days post-op ± 84 days 
60 Month Follow-up (if applicable) 
1825 Days post-op ± 84 days 
72 Month Follow-up (if applicable) 
2190 Days post-op ± 84 days 
 
7.6 Required Study Visits 
Study specific procedures and assessments for all subject visits must be completed by persons authorized 
by the principal investigator and trained by the Tornier study team. 
7.6.1 Baseline Visit 
Subjects need to provide informed consent prior to any study specific procedures being performed and 
prior to providing subject information to the study sponsor.  Inclusion and exclusion criteria will be 
verified at the baseline visit.  Some of the inclusion/exclusion criteria need additional verification at the 
time of surgery.  The subject is enrolled once they provide consent. 
The following baseline data will be collected for all subjects prior to surgery.  The baseline visit must 
occur within 60 days prior to surgery, except for shoulder X-rays which must be performed within 90 
days prior to surgery.  If the timeline is exceeded, the baseline visit assessments or X-ray must be 
repeated.   
 
Informed consent  
 
Data privacy language where required by law  
 
Subject demographics, medical history, indication for arthroplasty, tobacco use 
 
Pain medications usage 
 
Instability 
o Sulcus sign 
o Anterior and Posterior drawer test 
 
X-ray – physician will utilize the X-rays to assess the glenoid using the following criteria: 
o Morphology (Walch Classification) [21] 
o Erosion (modified Favard Classification) [22] 
o Joint Space (subjective measurement) 

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 
X-ray – independent radiologist will utilize imaging to assess X-ray data (defined in Section 7.3) 
 
ROM test 
 
Strength test 
 
Subject Questionnaire (FCI will only be completed at baseline) 
CT Scan is recommended for the most accurate assessment of glenoid type if there is concern regarding 
the glenoid bone stock.  CT data is not required but may be reported if collected per investigators standard 
of care. 
MRI is recommended to confirm the integrity of the rotator cuff (cuff tear and fatty infiltration) if there is 
a clinical question about the cuff integrity.  MRI data is not required but may be reported if collected per 
investigators standard of care. 
7.6.2 Day of Surgery 
The general surgical procedure is described in Section 4.3.  It is required that an investigator or sub-
investigator perform the surgical procedure.  During the surgery, the investigator will be required to 
assess the following exclusion criteria prior to implanting the Pyrocarbon HH.  A subject will not have a 
Pyrocarbon HH implant attempt and will be considered an intra-operative screen failure if any of the 
following conditions are present. 
 
In the opinion of the clinician, there is insufficient bone stock to support implants in the humeral 
metaphysis or poor bone quality. 
 
In the opinion of the clinician and prior to any glenoid treatments, there is insufficient bone stock 
or excessive deformation of the native glenoid to allow normal functioning of the glenohumeral 
joint. 
 
A rotator cuff that is not intact and cannot be reconstructed.  Subjects with a massive rotator cuff 
tear (>5cm) must be excluded. 
 
Anatomy cannot be adequately replicated using current available system sizes. 
If any of the aforementioned conditions are present, the implanting physician should utilize his or her 
standard bailout procedure.  Bailout procedures may include, but are not limited to: traditional total 
shoulder arthroplasty, reverse shoulder arthroplasty, another hemi shoulder arthroplasty device, or no 
implant. 
The following data associated with the surgery will be collected and reported into the study database: 
 
Pregnancy Test 
 
Intraoperative data and observations 
 
Adverse events 
 
Pain medication usage 
7.6.3 Rehabilitation Guidelines 
This section describes the recommended guidelines for the subject’s rehabilitation program.  
These guidelines may be modified by the surgeon using his/her judgment taking into 
consideration the subject’s pathology and physical condition. 
1. Subjects should wear the sling every night for at least the first 6 weeks. 

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2. Subjects should push themselves up in bed or from a chair using their non-surgical arm. 
3. Subjects should follow their program of home exercises and don’t do more than prescribed, as 
overuse of the shoulder can be harmful. 
4. No sports or heavy lifting for at least 4-6 months. 
5. Investigators will let the subject know when it is safe to drive. 
6. Investigators should provide subjects with a specific rehabilitation protocol.   
 
Passive motion only for up to 4 weeks after surgery.   
 
Begin passive assisted forward elevation and external rotation on the first day after 
surgery.   
 
Place no limit to forward elevation, but limit external rotation to the side to 30 degrees.   
 
At two weeks, begin internal rotation stretching.  Encourage active use of the arm for 
activities of daily living.   
 
Active assistive motion may be initiated at 3-4 weeks. 
 
Active phase initiated at 6-8 weeks, limit external rotation to 45 degrees and internal 
rotation to L5. 
 
Isometric phase may be initiated at 3 months.    
 
No vigorous strengthening until 20 weeks post-op 
The study specific guidelines (Appendix 3) should be provided to subjects upon hospital discharge.   
7.6.4 Post-op Follow-up 
Subjects will be seen between 5-21 days after the surgery for a post-op follow-up visit.  The main purpose 
of this visit is to assess the subject for adverse events and obtain an x-ray.  The following data will be 
collected and reported in the database: 
 
Adverse event assessment 
 
Pain medication usage  
 
X-ray – independent radiologist will utilize imaging to assess X-ray data (defined in Section 7.3) 
7.6.5 Follow-up:  3 Months and 6 Months 
Subjects will be seen three months post op (± 21 days), and six months post-op (± 21 days).  The main 
purpose of these visits is to assess the subject for adverse events and collect the data required to calculate 
all outcome measures (ASES, Constant score, Age Adjusted Constant Score, SANE, EQ-5D, subject 
satisfaction, pain).  ROM and Strength tests are optional at both three and six month visits.  X-rays are not 
completed at 3 months.  The following data will be collected and reported in the database: 
 
Adverse event assessment 
 
Pain medication usage  
 
X-ray (6 month only) – independent radiologist will utilize imaging to assess X-ray data (defined 
in Section 7.3) 
 
Subject Questionnaire 
 
ROM test (optional) 
 
Strength Test (optional) 

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7.6.6 Follow-up:  Annual 
Subjects will be seen 12 months post-op (± 42 days), 24 months post-op (± 42 days), and annually 
thereafter until the last implant attempt subject completes their 24 month post-op visit or determined lost 
to follow-up.  Annual visits, after 24 months, will have a window of ± 84 days.  The main purpose of the 
these visits is to assess subjects for adverse events and collect the data required to calculate all outcome 
measures (ASES, Constant score, Age Adjusted Constant Score, SANE, EQ-5D, subject satisfaction, 
pain).  The following data will be collected and reported in the database:  
 
Adverse event assessment 
 
Pain medications 
 
X-ray – independent radiologist will utilize imaging to assess X-ray data (defined in Section 7.3) 
 
Subject Questionnaire 
 
ROM test 
 
Strength test 
Subjects may be asked to return for additional visits after the study is completed, if deemed necessary.   
7.6.7 Follow-up: Pre-Operative Screen Failures 
Reason for the pre-operative screen failure will be documented on the eligibility form and then the subject 
will be exited. 
7.6.8 Follow-up: Intra-Operative Screen Failures 
Reason for the intra-operative screen failure will be documented on the eligibility form.  Subjects will be 
seen at 12 and 24 months to gather available safety information.  These visits may occur over the phone if 
the subject is unable to attend in person.  Subjects will be exited after the 24 month visit. 
7.6.9 Follow-up: Unsuccessful Implant Attempt 
Reason for the unsuccessful implant attempt will be documented on the surgical form.  Subjects will be 
seen at 12 and 24 months to gather available safety information.  These visits may occur over the phone if 
the subject is unable to attend in person.  Subjects will be exited after the 24 month visit. 
7.6.10 Follow-up: Revisions  
If a subject has revision surgery, the subject shall remain in the study and complete all required follow-up 
visits.  
7.6.11 Follow-up: Explants  
Subjects who have the Pyrocarbon HH explanted shall remain in the study and complete annual follow-up 
visits to gather available safety data 
7.7 Additional Data Collection 
Subjects may call or visit the investigative site at times other than for required study visits.  It is only 
required to notify Tornier if the visit or phone call is associated with an adverse event, revision, device 
explant, reoperation, device malfunction, subject death, or study exit.  Data associated with these events 
must be documented and reported in the database on the associated eCRFs. 
 

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Revision and Device Explants 
A revision is a procedure that adjusts or in any way modifies or removes any component of the original 
implant configuration, with or without replacement of a component, after the initial surgery. A revision 
may also include adjusting the position of the original configuration.   
An explant is a revision that includes permanent removal of any system component.  If a subject has a 
revision that includes an addition of a glenoid component (revision to TSA) the Pyrocarbon humeral head 
must be permanently explanted.   
All explanted system components, including the Pyrocarbon HH devices and stems, must be returned to 
Tornier for analysis per the system retrieval and analysis protocol in Appendix 4.   
Reoperation 
A reoperation is any invasive procedure to the affected shoulder that does not include removal, 
modification or addition of any components to the original implant configuration (e.g., drainage of a 
hematoma at the surgical site).  Subjects will not be considered a failure solely due to a reoperation and 
will follow their original follow-up schedule. 
Device Malfunction 
All failures and malfunctions of the implant system must be reported to Tornier as soon as possible.  In 
the event of a system malfunction, every effort must be made to return the suspected system to Tornier for 
analysis. 
Death 
During the study, all deaths must be reported to the Sponsor within 10 working days of the study 
personnel’s knowledge of the death.  A copy of death records, medical records for the events that led to 
the subject’s death, death certificate (if available) and an autopsy report (if performed) must be sent to the 
Sponsor as soon as they become available. 
7.8 Study Exit 
Subjects will exit the study after the last subject with an implant attempt completes their 24 month follow-
up visitor is determined lost to follow-up.  Reasons for exiting a subject early may include: 
• 
Subject voluntary withdraw of participation 
• 
Investigators may withdraw subjects from the study if the investigator feels it is in the subject’s 
best interest to withdraw or if the subject demonstrates non-compliance to the CIP. 
• 
Death 
• 
Subject lost to follow-up. 
• 
It was determined that subject did not meeting inclusion/exclusion criteria prior to surgery (pre-
operative screen failure) 
In the case that the subject is determined to be lost to follow-up, at least three documented attempts must 
be made to contact the subject and at least one of the attempts must be in writing via certified letter.  
Subjects who exit the study prior to study completion will not be replaced. 

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8 Investigational Device Handling and Traceability 
The Ascend Flex System stems and associated instruments are not investigational and will not require 
tracking while at the investigative site.  When the Pyrocarbon HH is paired with the Ascend Flex stem, 
and implanted in the body, the system (Pyrocarbon HH and Ascend Flex Stem) are both considered 
investigational and require tracking. 
The Pyrocarbon HH is investigational and will be tracked from the time it is shipped from Tornier until it 
is either implanted into a study subject, or returned to Tornier after completion of the enrollment.  A 
Device Accountability Log will be maintained at each study site and will be provided by Tornier in the 
Regulatory Binder.  Devices allocated for investigational site use will be recorded in the Device 
Accountability Log upon delivery to the study site and will be stored in a secured area until use.  No 
devices will be shipped to an investigative site until the site receives IRB approval to conduct the study.  
Each site will be responsible for tracking the receipt and disposition of all study devices. All unused study 
devices must be returned to Tornier.  
The Device Accountability Log will be updated as devices are received, opened, used or returned.  It will 
contain: receipt dates of devices and their lot or serial numbers; subject study identification number and 
their implant dates; and dates devices were returned to Tornier, along with the reason for the return. 
9 Study Deviations 
A study deviation is defined as an event within a study that did not occur according to the CIP or the 
CTA.  Prior approval by the Tornier Clinical Study Manager is expected in situations where the 
investigator anticipates, contemplates, or makes a conscious decision to deviate.  Prior approval is not 
required when a deviation is necessary to protect the life or physical well-being of a subject in an 
emergency or in unforeseen situations beyond the investigator’s control (e.g., subject failure to attend 
scheduled follow-up visits, inadvertent loss of data due to computer malfunction, etc.).  All study 
deviations must be reported regardless of whether medically justifiable, pre-approved by Tornier, an 
inadvertent occurrence, or done to protect the subject in an emergency.  The deviation must be recorded 
with an explanation for the deviation.  Reporting of deviations must comply with IRB policies, local laws, 
and/or regulatory agency requirements.  An investigator shall notify Tornier and the reviewing IRB of any 
deviation from this CIP taken to protect the life or physical well-being of a subject in an emergency.  This 
must be given as soon as possible, but in no event later than 5 working days after the emergency occurred.  
Tornier is responsible for analyzing deviations, assessing their significance, and identifying any additional 
corrective and/or preventive actions (e.g. amend the CIP, conduct additional training, etc.).  Repetitive or 
serious investigator compliance issues may require initiation of a corrective action plan with the 
investigator, and in some cases, necessitate suspending site enrollment until the problem is resolved or 
ultimately terminating the investigator’s participation in the study.   
10 Adverse Events 
10.1 Adverse Event Assessment Process 
An adverse event (AE) assessment must be completed for each subject at every study visit.  Ongoing AEs 
will be assessed at each study visit and the update reported to Tornier.  If the AE is still unresolved at 
study exit, it must be updated to state “unresolved at study exit”. 

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If the subject is treated by a health-care professional other than the investigator for treatment-related AEs, 
the investigator must request copies of the medical records and complete all required AE data collection.  
If the investigator is unable to obtain these medical records, efforts to obtain them should be documented 
in the subject’s medical record. 
10.2 Adverse Event Definitions 
 
Adverse Event (AE):  An Adverse Event is any unfavorable or unintended sign, symptom, condition or 
disease in a study subject, where the experience occurs during the course of the study; regardless of its 
relationship to the test product or surgical procedure. 
An Adverse Event may be volunteered spontaneously by the subject or discovered as a result of 
questioning or by physical examination by the Investigator or clinical study, or recorded anywhere in the 
patient’s medical record.  An Adverse Event must be documented in the progress notes and on an AE 
eCRF. 
For the purpose of this study, investigators are required to report all adverse events.  
The relationship of the AE to the study system or the implant procedure will be determined by the 
investigator and reported on the eCRF.  An independent physician consultant will review each reported 
AE for appropriate classification.   
Device Related:  An AE that results from the presence or performance of the device. 
Procedure Related:  An AE that occurs as a result of the implant procedure.   
Definitions of Relatedness: 
 
Definite:  A definite or certain association exists between the AE and the study device/system or 
implant procedure.   
 
Possible:  The AE cannot be explained by other causes (underlying disease, concomitant medical 
or concurrent treatment) and is possible that the AE occurred as a result of the study 
device/system or implant procedure.   
 
Not related:  The AE has no relationship with receipt of the study device or implant procedure, 
or it can be explained by other factors; including underlying disease, concomitant medication or 
concurrent treatment.   
Unavoidable Adverse Events: those that are expected to occur and inherent with the surgical procedure.  
These only need to be reported if they are deemed by the investigator to be more serious in duration or 
intensity than expected.  Unavoidable AEs include: 
• 
Anesthesia related nausea/vomiting 
• 
Low-grade fever for ~48 hours post-op 
• 
Incisional pain for ~72 hours post-op 
• 
Mild to moderate bruising or hematoma for ~ one week post-op 
• 
Sleep problems (insomnia) for ~ 72 hours post-op 
• 
Back pain related to lying on table 

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• 
Normal incision redness 
Serious Adverse Event (SAE) 
An adverse event is serious when it: 
• 
Led to death, 
• 
Led to serious deterioration in the health of the subject, that either resulted in 
o A life threatening illness or injury, or 
o A permanent impairment of a body structure or a body function, or 
o In-patient or prolonged hospitalization, or  
o Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
• 
Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
Unanticipated Adverse Device Effect (UADE) 
Any serious adverse effect on health or safety, any life-threatening problem or death caused by, or 
associated with a device, if that effect, problem, or death was not previously identified in nature, severity, 
or degree of incidence in the study protocol or informed consent; or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of subjects.   
Anticipated Adverse Events 
The risks associated with the Pyrocarbon HH used with the Ascend Flex stems are listed below.  The 
complications could cause inflammation, resulting in increased pain and the need for revision surgery. 
 
Dislocation 
 
Component loosening 
 
Component breakage 
 
Component wear 
 
Component migration 
 
Delayed wound healing 
 
Bone resorption 
 
Glenoid erosion 
 
Poor bone growth 
 
Over tension of the soft tissues 
 
Impingement of tendons or bursa in the shoulder from bones of the shoulder 
 
Rotator cuff tear 
 
Instability 
 
Stiffness 
 
Weakness 
 
Chronic postoperative pain/disability 
 
Nerve damage causing paralysis 
 
Tissue lesion 
 
Vascular Injury 

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 
Infection or any other event that could follow surgery (pulmonary embolism, heart attack, etc.) 
 
Fracture below the humeral implant. 
 
Possible metal sensitivity 
 
Oversized or undersized humeral head (the “ball portion”) could cause loss of mobility and pain. 
10.3 Adverse Event Reporting 
Adverse events shall be submitted to Tornier via the electronic data capture (EDC) system. 
Unanticipated Adverse Device Effects must be reported by the investigator to the Sponsor and IRB as 
soon as possible, but no later than 10 working days after the investigator first learns of the effect.  The 
sponsor shall report the results of the evaluation of a UADE to all reviewing IRB’s and participating 
investigators within 10 working days after the sponsor first receives notice of the effect.  If a UADE is 
determined to pose an unreasonable risk to study subjects, the study must be suspended within 5 business 
days of that determination but no later than 15 days from awareness of the event. 
All adverse events and device deficiencies will be forwarded to the appropriate Tornier Complaint 
Handling group per Tornier Standard Operating Procedures. 
Table 5:  Adverse Event Reporting Requirements 
AE Type 
Reporting Requirements 
AE  
 
Complete eCRF and report to the IRB per the IRB guidelines. 
Serious AE  
 
Complete eCRF and inform Sponsor as soon as possible 
(preferably within 10 days) and report to IRB per their 
guidelines. 
Unanticipated Adverse Device 
Effect 
Report to Sponsor and IRB as soon as possible but no later than 
10 working days of knowledge of the event. 
 
10.4 Adverse Event Review 
All reported AEs will be reviewed by a physician independent of the study (not participating as a PI).  
They will be reviewed individually to determine if they were classified appropriately according to the 
definitions in the CIP.  AEs will be reviewed in aggregate with the Clinical Study Manager periodically 
throughout the study.  During the aggregate data reviews, AEs and device deficiencies will be analyzed 
for important safety information. 
11 Risk Analysis 
11.1 Potential Risks 
There are risks to the subject associated with study participation.  The risks include standard surgical and 
anesthesia risk, risks associated with the Ascend Flex System, additional risks associated with the 
Pyrocarbon HH (investigational piece of the system), risks associated with the clinical study procedures, 
and standard risks of participating in a clinical study. 
Surgical implantation involves the same risks and discomforts associated with any other kind of surgical 
procedure and use of anesthesia.  In general, a subject could experience allergic reaction to medicines, 
breathing problems, bleeding, blood clot and infection. 

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The risks associated with the Pyrocarbon HH used with the Ascend Flex System are listed in the 
Anticipated Adverse Event section.   
The risks of participating in this clinical study include: 
 
Study participation requires that the subject undergo at least five x-rays over the course of two 
years.  Exposure to radiation is a risk associated with X-ray imaging. 
 
There are standard risks of participating in a research study which include the loss of 
confidentiality.  Every attempt will be made to ensure subject confidentiality. 
The risks of harm to the fetus is unknown, should a subject become pregnant.   
11.2 Risk Minimization 
The potential risks associated with the Pyrocarbon HH were identified and have been mitigated. Risks are 
mitigated through design, bench testing, design verification testing, quality checks in manufacturing, 
labeling (warnings and contraindications), and physician training. Any potential risks associated with this 
study are further minimized by selecting qualified investigators and training study personnel on the CIP.  
In addition, investigators will be actively involved in the surgery and follow-up of the subjects implanted 
with the Pyrocarbon HH.  Risks will be minimized by careful assessment of each subject prior to, during, 
and after implant of the device.  Tornier has further minimized risks by: providing guidelines for subject 
selection and evaluation, and providing adequate instructions and labeling for the investigational device. 
Subjects will be followed at regular intervals to monitor the condition of the shoulder system after 
implantation. At each protocol required follow-up, the investigator or designee must assess the subject for 
adverse events.  Investigators and sub-investigators are required to have sufficient experience with the 
Ascend Flex System before they can use it with the Pyrocarbon HH. 
11.3 Potential Benefits 
The Pyrocarbon HH may offer no additional benefit over currently available arthroplasty systems.  The 
potential benefits of having a Pyrocarbon HH includes less wear on the native glenoid than traditional 
CoCr humeral heads.  This could result in less pain and fewer or less frequent revision surgery.  The 
information gained from this study could result in the product being approved by the FDA and available 
to persons outside of the clinical study.  Additionally, the information collected from this study may assist 
in the design of new products, therapies, and instructions for use.  There is no guarantee that subjects will 
have any benefit from participating in the study. 
12 Planned Study Closure, Early Termination of Study or Study Suspension 
12.1 Planned Study Closure 
Study closure is a process initiated once all subjects have completed their final study visit. The process is 
complete when all Tornier and/or regulatory requirements have been fulfilled and upon distribution of the 
final report and closure letter.  IRB renewals/approvals are required until the overall study closure process 
is complete. 
12.2 Early Termination or Suspension 
Early termination is the closure of this clinical study at a site that occurs prior to the planned study 
closure.  This is possible for the whole study (all sites) or a single site.  Study suspension is a temporary 

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postponement of study activities related to enrollment.  This is possible for the whole study (all sites) or a 
single site.   
Possible reasons for considering study suspension or premature termination of the whole study may 
include: 
 
Observed/suspected performance different from the product’s design intent 
 
Decision by Tornier or regulatory body 
Possible reasons for clinical investigator or site termination or suspension include, but are not limited to:  
 
IRB approval expiration while the study is in progress. 
 
Consistent non-compliance to the clinical investigation (e.g. failure to adhere to 
inclusion/exclusion criteria, failure to follow subjects per scheduled follow-up visits, etc.). 
 
No subject enrollments within six months of study activation.   
 
Noncompliance to regulations and the terms of the CTA (e.g., failure to submit data in a timely 
manner, failure to accommodate a monitor, etc.). 
 
IRB suspension of the site. 
If Tornier terminates or prematurely suspends the study, the investigators will be promptly informed of 
the rationale.  Regulatory authority(ies) will be informed where required per regulatory requirements.  In 
the case of study termination or suspension for reasons other than a temporary IRB approval lapse, the 
investigator will promptly inform the IRB.  In the case of study termination, the investigator must inform 
the subjects.  In the case of study suspension, subjects already enrolled may continue to be followed in the 
study unless prohibited by the IRB. 
If the investigator terminates or suspends the study without prior agreement of Tornier, the investigator 
will promptly inform Tornier and provide a detailed written explanation of the termination or suspension.  
The investigator will promptly inform the institution (where required per regulatory or local 
requirements), the IRB, and the subjects.   
If the IRB terminates or suspends its approval of the study, the investigator will promptly inform Tornier 
and provide a detailed written explanation of the termination or suspension.  Subject enrollment must stop 
until the IRB suspension is lifted.  Subjects already enrolled should continue to be followed in accordance 
with IRB policy or its determination that an overriding safety concern or ethical issue is resolved.  The 
investigator will inform his/her institution (where required per regulatory or local requirements).  The 
investigator will promptly inform the subjects of the rationale for the study termination or suspension. 
13 Statistical Methods and Data Analysis 
More detailed analyses will be provided in a separate Statistical Analysis Plan.  The SAP will be 
submitted to the FDA with the IDE.  The final SAP will include the additional details of the methods for 
group comparability and outcome comparison. 
13.1 General Methods 
The Intent-to-Treat (ITT) population will consist of all subjects who have undergone attempted or 
successful implantation of the test system. The Per-Protocol (PP) population will include all subjects who 
have undergone successful implantation of the test system, completed 24 months of follow-up, and have 

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had no major protocol violations (defined as not meeting inclusion/exclusion criteria or not being 
consented properly).  The primary composite endpoint analyses will be performed on the ITT population. 
Analysis of the PP population will used in support the ITT analyses. The safety analysis will be 
performed on the ITT population. 
 
Data will be summarized using descriptive statistics.  Continuous data will be summarized using mean, 
standard deviation, minimum, and maximum.  Where appropriate, non-parametric measures of location 
(e.g. median, interquartile range) may be provided.  For categorical data frequencies and percentages will 
be provided.   
 
All statistical analyses will be completed using SAS software (SAS Institute, Inc., SAS Campus Drive, 
Cary, NC 27513, USA.). In the event an analysis is required that is better suited for a statistical package 
other than SAS, another package may be used. 
13.2 Primary Endpoint 
The primary study endpoint will be compared for non-inferiority to a performance goal success rate of 
85%.  The Tornier Aequalis Post-Market Outcomes Study is the source of the data for the control group 
that was used to create the performance goal.  Subjects with the appropriate indications with at least two 
years of follow up data (or revision prior to two years) were included in the cohort used to calculate the 
performance goal. 
13.2.1 Hypothesis Test 
The primary endpoint will evaluate the non-inferiority of the composite success endpoint to the Aequalis 
dataset rate.   
 
Formally, the hypothesis to be tested is: 
H0: p ≤ PG - δ 
HA: p > PG - δ 
 
Where p is the proportion of subjects with a success for the composite success endpoint, PG is the 
performance goal (Aequalis dataset rate), and δ is the non-inferiority margin.   
 

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13.2.2 Sample Size 
Statistical considerations for powering the primary endpoint include the following: 
 
80% power with a one-sided 0.025 level of significance 
 
Non-inferiority test of one proportion  
 
10% non-inferiority margin, and performance goal of 85%  
 
Assumed  success rate of 85%  
 
Attrition rate of 15% 
The sample size for this endpoint was calculated using SAS (Version 9.3) under a one-sided z-test of a 
binomial proportion.  The minimum required sample size is estimated using the above list of statistical 
considerations.  The resultant sample size under these assumptions is 133 subjects with an implant 
attempt and evaluable endpoint data.  With 15% attrition, 157 total implant attempts are needed. Up to 
190 subjects may be enrolled to account for pre and intra-operative screen failures.  Enrollment will stop 
once 157 subject have had an implant attempt. 
13.2.3 Analysis 
The number and proportion of subjects reaching the composite success outcome will be summarized.  
Additionally, a 95% confidence interval (CI) will be calculated for the proportion.  The non-inferiority of 
the test system to the performance goal will be evaluated using the 95% CI for the observed test system 
success rate.  The study will be considered a success if the lower bound of the confidence interval is 
greater than 75% (85% - 10%). 
The primary analysis will be based on the ITT population with available 24 month data.  A supportive 
analysis based on the PP population will also be presented.  The impact of missing 24 month data will be 
evaluated through sensitivity analyses, described in the next section. 
13.2.4 Missing Data 
The impact of missing data due to loss to follow-up prior to 24 months will be assessed by sensitivity 
analyses. The primary endpoint analysis will be repeated once under the assumption that all missing 
subjects were successful, a second time under the assumption that all missing subjects were failures, as 
the most conservative assessment, and a third time using multiple imputation for missing values. The 
results of these analyses will be presented. 
13.3 Secondary Endpoints 
13.3.1 Inferential Secondary Endpoints 
The following secondary data will be evaluated for significant change from baseline to 24 months.   The 
overall type I error will be controlled using the Hochberg method for adjusting for multiple comparisons, 
and will be tested only if the primary endpoint is met.  Endpoints will be evaluated at a one-sided alpha 
level of 0.025. 
 
Constant Score and Adjusted Constant score 
 
American Shoulder and Elbow Surgeons (ASES) Score 

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 
Single Assessment Numeric Evaluation (SANE) 
 
EQ-5D 
 
Pain (VAS) 
 
Range of Motion 
 
Strength 
13.3.1.1 Hypothesis Tests 
The hypothesis test for each of the above endpoints, with the exception of Pain (VAS), will be of the 
form: 
H0: µ ≤ 0 
HA: µ > 0 
 
Where µ is the mean change from baseline to 24 months (follow-up minus baseline) for that endpoint.   
The hypothesis test for the Pain (VAS) endpoint will be of the form: 
H0: µ ≥ 0 
HA: µ < 0 
 
Where µ is the mean change from baseline to 24 months (follow-up minus baseline) in the VAS Pain 
score. 
13.3.1.2 Analysis 
For each endpoint, descriptive statistics will be provided for subjects at baseline and 24 month follow-up.  
The difference from baseline to 24 months will be summarized using descriptive statistics, and a paired t-
test will be performed.  Additionally, the 95% confidence interval will be calculated for the change from 
baseline. 
13.3.2 Additional Secondary Endpoints 
The following secondary endpoints will be presented using descriptive statistics only. 
 
Adverse events 
 
Revision rate 
 
Level of satisfaction with the shoulder 
 
X-ray data: glenohumeral joint space width, glenoid osteophytes, glenoid morphology, glenoid 
erosion, humeral component radiolucency, osteolysis, migration, subsidence, subluxation, 
humeral head integrity, acromiohumeral distance, anatomic fracture, and additional observations 
 
Note that safety is included in the primary composite endpoint and also as a descriptive secondary 
endpoint.  The objective of the safety analysis is to demonstrate that the test system has an acceptable 
safety profile. Adverse events will be summarized by the proportion of subjects with serious adverse 
events, system-related adverse events and unanticipated adverse device effects.  Subjects with system 
related SAEs will be counted as a failure towards the composite endpoint. 
13.4 Baseline Assessment 
Demographics and baseline characteristics will be assessed by descriptive statistics. These factors will 
include (but not be limited to): 
 
Age 

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 
Sex 
 
Body Mass Index (BMI) 
 
Medical history (included diagnosis) 
 
Constant Score 
 
Adjusted Constant score 
 
EQ-5D 
 
Pain  
13.5 Comparability to Aequalis Dataset 
Demographics and baseline characteristics for subjects in the Aequalis dataset and subjects with the test 
system will be compared by t-tests for continuous factors and chi square tests for categorical factors, non-
parametric or exact tests may be used when appropriate. These characteristics will include age, gender, 
diagnosis, and baseline adjusted Constant score. Additional baseline measures may be considered if 
sufficient non-missing values are available. A propensity score analysis may also be performed on the 
subjects with complete 24 month status/data available.  The propensity score analysis will incorporate 
data from Aequalis dataset used to derive the performance goal and subjects enrolled in the current 
investigation. If significant differences are found between groups, the impact of relevant factor(s) on 
success rates will be assessed by logistic regression. 
13.6 Poolability 
A pooling analysis will be performed to assess the poolability of sites with respect to the primary 
endpoint measure in the ITT subjects. A Fisher’s Exact Test will be used to test for a difference in 
composite success rate across sites. A significance level of 0.1 will be used to determine whether the sites 
are poolable. If a significant difference is found between sites, additional analyses will be done to identify 
factors that may be associated with this difference.   Additionally, if a significant difference is observed, a 
random site adjusted estimate of the composite success rate, along with 95% CI, will be provided. 
Although enrollment will be monitored in an effort to strive for even allocation between sites, for 
purposes of the poolability analysis those sites with less than five (5) evaluable patients enrolled will be 
combined into a pseudo-site for purposes of analysis.  To protect against having an overly large pseudo-
site, when one pseudo-site exceeds five (5) evaluable, a second pseudo-site will be formed.  This process 
will continue as needed each time a pseudo-site exceeds five (5) evaluable. 
14 Data and Quality Management 
All information and data sent to Tornier concerning subjects or their participation in this study will be 
considered confidential.  All data used in the analysis and reporting of this clinical study will be used in a 
manner without identifiable reference to the subject.  The investigator consents to visits by Tornier staff 
and authorized governmental bodies to review the study subjects’ medical records, including any test or 
laboratory data that might have been recorded on diagnostic test media (e.g., X-rays). 
Data will be stored in a secure, password-protected database. Data will be reviewed using programmed 
and manual data checks.  Data queries will be made available to sites for resolution.  Study management 
reports may be generated to monitor data quality and study progress.  At the end of the study, data will be 
frozen and retained by Tornier per document retention policies at the time of study termination.  
Procedures for data review, database cleaning, issuing and resolving data queries, verification, validation 
and securing of electronic clinical data systems, and data retention will be documented separately. 

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15 Monitoring, Auditing, and Inspecting 
15.1 Monitoring Plan 
It is the responsibility of Tornier to ensure proper monitoring of the study per regulations.  Trained 
Tornier personnel or delegates appointed by Tornier will perform study monitoring at the study site in 
order to ensure the study is conducted in accordance with the CIP, the CTA, and applicable regulatory 
requirements.  Tornier must therefore be allowed access to the subject’s clinic and hospital records when 
so requested as per the subject informed consent document, Privacy Authorization, and CTA. 
The primary focus of the monitoring visits will be on the processes critical to protecting human subjects, 
maintaining the integrity of study data, and compliance with applicable regulations.  The findings will be 
used to correct investigator and site practices that could result in inadequate human subject protection 
and/or poor data quality.  Both on-site and centralized monitoring will be conducted as detailed in the 
study Monitoring Plan.  The Monitoring Plan will include a risk assessment that considers the types of 
data to be collected, the specific activities required to collect the data, and the range of potential safety 
and other human subject protection concerns associated with specific data points.  The risk assessment 
will determine the type, frequency, and intensity of monitoring activities that will be performed and will 
be documented separately in the monitoring plan. 
15.2 Audits 
In the event of any inspection by any Regulatory Authority, the investigators agree to cooperate with 
representatives of the Regulatory Authority, and to provide the Regulatory Authority representative 
access to records as required by applicable Laws. Site personnel shall immediately notify Tornier upon 
learning that an inspection by a Regulatory Authority is scheduled to take place, or, if there is no prior 
notice by the Regulatory Authority, that an inspection has commenced relating to the Study. If any 
Regulatory Authority issues any notice of observations or warning letter relating to the Study, the 
investigator shall send a copy of the document to Tornier and provide Tornier with a copy of a draft 
response. 
16 Medicare Study Criteria 
It is not anticipated the device under investigation will affect the Medicare population any differently than 
patients found the investigators' general population for patients requiring treatment for shoulder pain 
including populations eligible for Medicare due to age (e.g., 65 years or older), disability, or other 
eligibility status. The study's subject selection will include adults 22 years or older. Because the study's 
inclusion criteria includes an adult patient population with no upper age limit, it is anticipated the study's 
enrolled population will be represented by a proportion of patients eligible for Medicare primarily due to 
age (E.g., 65 years or older). Moreover, the strength of each subject’s normal shoulder may differ because 
gender and age differences as measured by the study's Constant score test. This test will be administered 
according to a modification of the standard procedure established in the updated paper by Constant, et al. 
in the Journal of Shoulder and Elbow Surgery, 2008 [2]. The Constant score calculation will be adjusted 
using normative values for the Constant score based on age and gender. Because the Adjusted Constant 
score will be adjusted using normative values for the Constant score based on age and gender, this 
outcome measure is expected to be generalizable to the Medicare beneficiary population due to age (e.g., 
65 years or older) but not necessarily due to disability or other eligibility status.  

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Access to clinical study data provides opportunities to conduct further research that can help advance 
medical science or improve patient care. This helps ensure the data provided by research participants are 
used to maximum effect in the creation of knowledge and understanding. To this end, the study's results 
information on all pre-specified outcomes, including negative outcomes, will be submitted to 
ClinicalTrials.gov not later than one year after the study completion date of the study, where the 
completion date is defined as the date that the final subject was examined or received an intervention for 
purposes of data collection for the primary outcome measure. Results submission could be delayed if an 
extension is granted to the results submission deadline; however, the release of all results on pre-specified 
outcomes will be hastened if the study is terminated early.  
17 Required Records and Reports 
Investigators and Tornier shall maintain records for this study for a period of at least 2 years after the date 
on which the investigation is terminated or completed.  An investigator may withdraw from the 
responsibility to maintain records for this period and transfer custody of the records to any other person 
who will accept responsibility for them. Notice of a transfer shall be given to FDA not later than 10 
working days after transfer occurs. 
17.1 Investigator Records 
The investigator is responsible for the preparation and retention of the records cited below.  All of the 
below records, with the exception of case history records and electronic case report forms, should be kept 
in the Investigator Site File (i.e., the study binder provided to the investigator), or Subject Study File.  
Electronic case report forms (eCRFs) may be maintained and signed electronically within the electronic 
data capture system during the study.   
 
All correspondence between the IRB, Sponsor, another investigator, monitor, FDA and/or the 
investigator that pertains to the investigation, including required reports. 
 
Subject’s case history records, including, but not limited to: 
o Signed and dated informed consent form 
o Signed and dated privacy authorization form (may be combined with the informed 
consent form) 
o Observations of adverse events/adverse device effects. 
o Medical history 
o Implant and follow-up data 
o Documentation of the dates and rationale for any deviation from the protocol. 
 
Signed and dated eCRFs 
 
Investigational device traceability records 
 
All approved versions of the CIP and Report of Prior Investigations 
 
Signed and dated CTA 
 
Investigator’s current CV 
 
Delegation of Authority Log 
 
IRB study approval documentation, including written confirmation that the investigator or other 
study staff, if a member of the IRB, did not participate in the approval process.   

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17.2 Investigator Reports 
The investigator shall prepare and submit in a complete, accurate, and timely manner, the reports listed in 
this section. 
Table 6:  Investigator Reporting Requirements 
Report 
Submit to: 
Description/Constraints 
UADE 
Sponsor and IRB 
ASAP, but no later than 10 working days 
after the investigator first learns of the 
effect. 
Withdrawal of IRB approval 
Sponsor 
An investigator shall report to the sponsor, 
within 5 working days, a withdrawal of 
approval by the reviewing IRB. 
SAE  
 
Sponsor 
ASAP, preferably within 10 working days 
IRB 
Report per the IRB’s policies and 
procedures 
Deviations from the CIP 
Sponsor and IRB 
An investigator must notify the sponsor 
and IRB of any deviation from the CIP to 
protect the life or physical well-being of a 
subject in an emergency.  Such notice 
shall be given ASAP, but no later than 5 
working days after the emergency 
occurred. 
Failure to obtain informed 
consent prior to investigational 
device use. 
Sponsor and IRB 
If an investigator uses a device without 
obtaining informed consent, the 
investigator shall report such use within 5 
working days after device use. 
Final report 
Sponsor 
This report must be submitted within three 
months of study completion or 
termination of the investigation or the 
investigator’s part of the investigation.   
Progress 
Sponsor and IRB 
An investigator shall submit progress 
reports to the sponsor and IRB/MEC at 
regular intervals, but in no event less often 
than yearly. 
Other 
IRB and FDA 
An investigator shall, upon request by a 
reviewing IRB or FDA, provide accurate, 
complete, and current information about 
any aspect of the investigation  
Device Malfunction 
Sponsor 
ASAP, preferably within 24 hours of 
notice 
 
 

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17.3 Sponsor Records 
Tornier will maintain the following accurate, complete, and current records relating to this investigation: 
 
All correspondence with an investigator, an IRB, or FDA, including required reports. 
 
Records of shipment and disposition. Records of shipment shall include the name and address of 
the consignee, type and quantity of device, date of shipment, and batch number or code mark. 
Records of disposition shall describe the batch number or code marks of any devices returned to 
Tornier, repaired, or disposed of in other ways by the investigator or another person, and the 
reasons for and method of disposal. 
 
Signed investigator agreements including the financial disclosure information required to be 
collected under 812.43(c) (5). 
 
Records concerning adverse events. 
17.4 Sponsor Reports 
Table 7:  Sponsor Reporting Requirements 
Report 
Submit to: 
Description/Constraints 
UADE Evaluations 
FDA, all participating 
IRBs 
10 working days after the sponsor first 
receives notice of the effect. Thereafter, 
Tornier shall submit such additional reports 
concerning the effect as FDA requests. 
Withdrawal of IRB 
approval 
FDA, all reviewing IRBs 
and participating 
investigators 
Within 5 working days after receipt of notice 
of the withdrawal of approval. 
Withdrawal of FDA 
approval 
All reviewing IRBs and 
participating investigators 
Within 5 working days after receipt of notice 
of the withdrawal of approval. 
Current investigator list 
FDA 
Tornier shall submit, in 6 month intervals, a 
current list of the names and addresses of all 
investigators participating in the investigation. 
Progress Reports 
FDA and all reviewing 
IRBs 
At regular intervals, at least yearly 
Recall and device 
disposition 
FDA and all reviewing 
IRBs and participating 
investigators 
Any request that an investigator return, repair, 
or otherwise dispose of any unit of a device 
shall be reported within 30 working days after 
the request is made and shall state why the 
request was made. 
Completion or 
termination of the 
investigation 
FDA 
Within 30 working days 
Final Report 
FDA and all reviewing 
IRBs and participating 
investigators 
Within 6 months of study termination. 
Informed Consent 
FDA 
Within 5 working days of receipt of notice of 
device use without obtaining informed 
consent. 
Other 
FDA, reviewing 
IRB/MEC 
Provide accurate, complete and current 
information about any aspect of the 
investigation as requested at any time. 

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18 Publications 
Tornier will form a Publication Committee to manage publications that utilize data from this study.  The 
committee will develop a publication plan outlining the details related to primary, secondary, and 
ancillary publications and authorship rules.  The responsibilities of the committee will include reviewing 
publication ideas and proposals, providing input on their scientific merit and clinical relevance, and 
prioritizing them accordingly.  Membership in the publication committee or participation as an 
investigator in this study does not guarantee authorship. Publication Committee membership criteria will 
be established and documented by Tornier.  
Primary study results will be published following the final study analyses. 
The International Committee of Medical Journal Editors (ICMJE) authorship guidelines will be used.  
The ICMJE guidelines require the conditions below are met to be included as an author: 
 
Substantial contribution to conception and design, or acquisition of data, or analysis and 
interpretation of data 
 
Drafting the article or revising it critically for important intellectual content 
 
Final approval of the version to be published 
This study will be registered in www.clinicaltrials.gov, and results will be posted. 
 
 

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Appendix 1  References 
 
[1]  R. Richards, K. An, L. Biglianai, R. Friedman, G. Gartsman, A. Gristina and et. al., "A standardized 
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[2]  C. Constant, C. Gerber, R. Emery, J. Sojbjerg, F. Gohlke and B. Pascal, "A review of the Constant 
score: Modifications and guidelines for its use.," J Shoulder Elbow Surg., vol. 17, no. 2, pp. 355-
361, 2008.  
[3]  C. Constant, "Age related recovery of shoulder function after injury [MCh Thesis]," Univesity 
College, Cork, Ireland, 1986. 
[4]  D. Groll, T. To, C. Bombadier and J. Wright, "The development of a comorbidity index with 
physical function as the outcome.," Journal of Clinical Epidemiology, vol. 58, pp. 592-602, 2005.  
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[6]  C. I. Neer, "Replacement arthroplasty for glenohumeral osteoarthrits.," J Bone Joint Surg [Am], 
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[7]  O. Levy and S. Copeland, "Cementless surface replacement arthroplasty of hte shoulder: 5-10 year 
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2001.  
[8]  G. Gartsman, T. Roddey and S. Hammerman, "Shoulder arthroplasty wiht or without resurfacing of 
the glenoid in patients who have osteoarthrits.," J Bone Joint Surg Am, vol. 82, pp. 26-34, 2000.  
[9]  C. Radnay, K. Setter, L. Chambers, W. Levine, L. Bigliani and C. Ahmad, "Total shoulder 
replacement compared wiht humeral head replacement for the treatment of primary glenohumeral 
osteoarthritis: a systematic review.," J Shoulder Elbow Surg, vol. 16, pp. 396-02, 2007.  
[10] J. Pequignot and Y. Allieu, "Pyrocarbon proximal scaphoid implant allowing adaptative mobility in 
proximal scaphoid pseudarthrosis.," in The Scaphoid, 2011, p. Chapter 35. 
[11] A. Haubold, "On the durability of phyrolytic carbon in vivo," Med Prog Technol, vol. 20, no. 3-4, 
pp. 201-208, 1994.  
[12] S. Cook, K. Thomas and M. Kester, "Wear characteristics of the canine acetabulum against 
different femoral prosthesis.," J Bone and Joint Surg, Vols. 71-B, no. 2, pp. 189-197, 1989.  
[13] S. Cook, R. Beckenbaugh, A. Weinstein and J. Klawitter, "Pyrolite pyrocarbone implants int he 
metacarpophalangeal joint of baboons," Orthopedics, no. 6, pp. 952-961, 1983.  

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[14] S. Cook, R. Beckenbaugh, J. Redondo, L. Popich, J. Klawitter and R. Linscheid, "Long-term 
follow-up of pyrolytic carbon metacarpophalangeal implants," J Bone Joint Surg, Vols. 81-A, no. 5, 
pp. 635-648, 1999.  
[15] P. Strzepa and J. Klawitter, "Ascension PyroCarbon Hemisphere Wear Testing Against Bone," in 
51st Annual Meeting of Orthopedic Research Society.  
[16] H. Cao, "Mechanical performance of pyrolytic carbon in prosthetic heart valve applications.," J 
Heart Valve Dis, vol. 5, no. Suppl 1, pp. S32-49, 1996.  
[17] J. Koh, S. Levin, E. Chehab and G. Murphy, "Neer Award 2012: Cerebral oxygenation in the beach 
chair position: a prospective study on the effect of general anesthesia comparedwith regional 
anesthesia and sedation," J Shoulder Elbow Surgery, vol. 22, pp. 1325-1331, 2013.  
[18] G. Williams, D. Taylor, T. Gangel, J. Uhorchak and R. Arciero, "Comparison of the single 
assessment numeric evaluation method and the Lysholm score," Clin Orthop Relat Res, no. 373, pp. 
184-192, 2000.  
[19] M. Bahk, E. Keyurapan, A. Tasaki, E. Sauers and E. McFarlan, "Laxity testing of the shoulder: a 
review," Am J Sports Med, vol. 35, no. 1, pp. 131-44, 2007.  
[20] K. Hayes, J. Walton, Z. Szomor and G. Murrell, "Reliability o five methods for assessing shoulder 
range of motion," Aust J Physiother, vol. 47, no. 4, pp. 289-294, 2001.  
[21] G. Walch, R. Badet, A. Boulahia and A. Khoury, "Morphological study of the glenoid in primary 
glenohumeral osteoarthritis," J. of Arthroplasty, vol. 14, pp. 756-60, 1999.  
[22] C. Le´vigne, P. Boileau, L. Favard and e. al, "Scapular notching in reverse shoulder arthroplasty," J 
Shoulder Elbow Surg, vol. 17, no. 6, pp. 925-935, 2008.  
[23] J. Goldber, J. Gilbert, J. Jacobs, T. Bauer, W. Paprosky and S. Leurgans, "A multicenter retrieval 
study of the taper interfaces of modular hip prostheses," Clin Orthop Relat Res, no. 401, pp. 149-
164, 2002.  
[24] A. Tzannes and G. Murrell, "Clinical examination of the unstable shoulder," Sports Med, vol. 32, 
no. 7, pp. 447-457, 2002.  
[25] A. Farber, R. Castillo, M. Clough, M. Bahk and E. McFarland, "Clinical assessment of three 
common tests for traumatic anterior shoulder instability," JBJS, Vols. 88-A, no. 7, pp. 1467-1474, 
2006.  
 

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Appendix 2  Strength Testing Protocol 
The Constant Score 
This test will be administered according to a modification of the standard procedure established in the 
updated paper by Constant, et al. in the Journal of  Shoulder and Elbow Surgery, 2008 [2]. 
Further modifications to the described procedure for this test are related 
only to the use of equipment: 
1) For the strength component of the score, a fixed force gauge as 
depicted in Figure 6 will be used. 
2) For Visual Analog Scales (VAS), either a paper form with a 
graduated line or the study electronic database, will be used.  
 
Strength (Power) Measurement  
A fixed force gauge is a device for measuring force, moment of force 
(torque), or power.  It is used in shoulder orthopedics for measuring the 
arm strength of patients to evaluate physical status, performance and task 
demands. 
 
Method 
The evaluation method for this study will be performed using the fixed force gauge device supplied or 
approved by Tornier and a modification of the standard methods as described below [2] 
• 
The assessment will use a fixed force gauge as depicted in the photograph above. 
• 
The test position is the subject standing with the arm in 90° elevation in the scapular plane, elbow 
extended and forearm pronated. An adjustable strap is placed around the forearm just proximal to 
the radio carpal joint and attached to the fixed force gauge.  
• 
The fixed force gauge is firmly secured by the examiner. The subjects are instructed to pull 
upward with maximum effort until requested to stop.  
• 
The reading of the fixed force gauge is taken after five seconds of maximum effort.  
• 
At least one pull is required, but three are suggested.  All measurements will be collected. 
• 
Patients unable to reach the test position will receive the value of zero. 
 
Figure 7: Fixed Force 
Gauge 
Figure 6: Fixed Force 
Gauge 

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Appendix 3  Subject Rehabilitation Guidelines 
You are being asked to follow specific guidelines during your post-study implant rehabilitation.  Your 
doctor may provide you with more detailed instructions in addition to the study guidelines.  The following 
instructions inform you when to start using passive and active motion.  Passive motion is the use of an 
external force (e.g., other arm) to move your treated arm.  DO NOT use your treated arm muscles during 
passive motion.  Active motion is when you start using your muscles of the treated arm without 
assistance.   
Below are general guidelines to keep in mind during your recovery. 
 
Wear the sling every night for at least the first 6 weeks. 
 
Push yourself up in bed or from a chair using your non-surgical arm. 
 
Follow your program of home exercises and don’t do more than prescribed, as overuse of the 
shoulder can be harmful. 
 
No sports or heavy lifting for at least 4-6 months. 
 
Do not drive.  Your doctor will let you know when it is safe to drive 
 
After your surgery, you should limit your shoulder motion as follows 
 
Passive motion ONLY for up to 3 weeks.  
 
Limit forward elevation to 120 degree for the first 6-8 weeks.  (Figure 1)   
 
Passive external rotation to the side should be limited to 30 degrees (Figure 2).  
 
At 3-4 weeks you may begin active assistive motion.  During this phase you should begin using your 
treated shoulder muscles along with assistance (similar to the passive phase). 
 
At 6-8 weeks you may begin active motions without assistance.   Limit external rotation to 45 degrees 
and internal rotation to L5.  (Figure 3) 
 
Isometric strengthening phase may be initiated at 3 months.    
 
Do not begin any vigorous strengthening until 20 weeks after surgery. 
 
 
Figure 1: Active assisted Forward Elevation 

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Figure 2: External Rotation 
 
Figure 3: Internal Rotation 
 
 
 
Images adapted from http://shoulderarthritis.blogspot.com/2011_03_01_archive.html

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Appendix 4  System Retrieval and Analysis Protocol 
 
 
 
Pyrocarbon IDE Study 
Protocol #: 15A-T-PYC-R 
IDE#: G140202 
 
 
 
 
Device Retrieval and Analysis Protocol 
 
 
 
 
 
 
Version: 1 
Date:  Final – 17 July 2015 
 
Sponsor 
Tornier, Inc. 
10801 Nesbitt Ave South 
Bloomington, MN  55437 USA 
Phone:  952-921-7600 
Fax:  952-291-7601 
 
 
 
 
 
 
 
Confidential Information 
No use or disclosure of information contained within 
this document is permitted without prior written authorization from Tornier. 

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Contents 
1. 
Scope ................................................................................................................................................. 59 
2. 
References ........................................................................................................................................ 59 
3. 
Terms and Definitions ...................................................................................................................... 59 
4. 
Procedures for Retrieval, Handling, and Packaging ................................................................... 59 
4.1. 
Pre-explant functional check: ..................................................................................................... 59 
4.2. 
Explant record ............................................................................................................................... 60 
5. 
Collection of clinical history of the implant and patient ............................................................... 60 
6. 
Collection of tissue and fluid samples near the implant, ............................................................ 61 
7. 
Photographic record of the explanted device and tissues, ........................................................ 62 
8. 
Containing, labeling, cleaning, decontaminating, packaging and shipping of retrieved 
implant, tissue, or fluid samples, ............................................................................................................ 62 
8.1. 
Labeling the explanted materials for future identification ....................................................... 62 
8.2. 
Documentation .............................................................................................................................. 63 
8.3. 
Cleaning and Decontamination/Sterilization ............................................................................ 63 
8.4. 
Packaging and Shipping the explant for shipment .................................................................. 64 
9. 
Analysis of tissue and fluids............................................................................................................ 65 
9.1. 
Fluid analysis: ............................................................................................................................... 65 
9.2. 
Macroscopic Examination of Tissues: ....................................................................................... 66 
9.3. 
Histological procedure ................................................................................................................. 67 
9.3.1. 
Fixation: ..................................................................................................................................... 67 
9.3.2. 
Processing: ................................................................................................................................ 67 
9.3.3. 
Embedding ................................................................................................................................ 68 
9.4. 
Histological analysis ..................................................................................................................... 68 
9.4.1. 
Histopathological analysis ....................................................................................................... 68 
9.4.2. 
Immunohistological analysis ................................................................................................... 69 
9.4.2.1. 
Lymphoid populations .......................................................................................................... 69 
9.4.2.2. 
Histiocytic macrophage populations: ................................................................................. 69 
10. 
Analysis of retrieved components – Stage 1: visual analysis, ............................................... 70 
11. 
Analysis of retrieved components and records – stage 2: physical analysis, ..................... 74 
12. 
Analysis of retrieved components – stage 3: destructive analysis, ...................................... 75 
13. 
Determination of the mode and cause of failure...................................................................... 75 
14. 
Bibliography ................................................................................................................................... 76 

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1. Scope 
This process covers the retrieval, handling, and analysis of implanted Flex Shoulder 
System with Pyrocarbon humeral heads and associated specimens that are removed 
from subjects during revision surgery.  The aim is to provide guidance in preventing 
damage to the associated specimens which could obscure the investigational results, and 
in gathering data at the proper time and circumstance to validate the study. 
2. References 
- 
ASTM F561-13: Standard Practice for Retrieval and Analysis of Medical Devices, 
and Associated Tissues and Fluids 
3. Terms and Definitions 
- 
Antiseptic: A germicide that is used on skin or living tissue for the purposes of 
inhibiting or destroying microorganisms. 
- 
Decontamination: A process or treatment that renders a medical device, 
instrument, or environmental surface safe to handle.  Ranges from sterilization to 
cleaning with soap and water. 
- 
Disinfectant: A germicide that is used solely for destroying microorganisms on 
inanimate objects. 
- 
Disinfection: Generally less lethal than sterilization.  It eliminates virtually all 
recognized pathogenic microorganisms but not necessarily all microbial forms on 
inanimate objects.  It does not ensure overkill. 
- 
Sterilization: Use of a physical or chemical procedure to destroy all microbial life; 
including large numbers of highly resistant bacterial endospores.  
4. Procedures for Retrieval, Handling, and Packaging 
Any part of the Tornier Flex Shoulder System with a Pyrocarbon humeral head that is 
removed from a study subject must be returned to Tornier for analysis. 
Please contact Tornier Clinical Department to request a Return Material Authorization 
number (RMA) which details return instructions.    
The following steps are important and necessary to aid in the analysis of an explanted 
device: 
4.1. Pre-explant functional check: 
 Whenever possible, a pre-explant functional check of the implant is recommended 
to assist in post-explant analysis. Objective measurements of shoulder function 
should be obtained when possible. These measurements include: American 
Shoulder and Elbow Surgeons Standardized Shoulder assessment (ASES), 

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Constant score, Single Assessment Numeric Evaluation (SANE), and shoulder 
satisfaction (since they were used as measures of the system’s performance in 
this study) as well as other clinical indicators such as EQ5D, pain, tenderness, 
swelling, etc.   
 A non-invasive examination of the implanted system via X-ray should be performed 
in accordance with the Pyrocarbon IDE Study protocol X-ray procedures. 
4.2. Explant record 
 If any components are misaligned in any way due to migration or surgical mal-
positioning at the time of revision surgery, then every effort should be made to 
mark the components prior to removal in order to preserve their in situ orientation.  
Ideally, the operating surgeon should be asked to make a small mark(s) with a fine 
osteotome at the 12 o’clock (mid-line) position on the CrCo double taper neck 
component before dismounting from stem. The metallic osteotome should not 
touch the Pyrocarbon bearing surface component, otherwise it could damage it. If 
the bearing surface is damaged, the position of the contact/damage on the 
Pyrocarbon bearing surface would be recorded. If the implants are not marked 
before extraction or immediately after, then the true location of the wear 
scars/features can only be guessed.  If possible, photos of the marks made should 
be taken immediately after they are made.  If the 12 o’clock position is not 
accessible and another marking position is used, photographic records as well as 
a written note of the position should be documented. 
 Shortly after removal, a detailed record of any damage caused to the components 
during extraction should be documented, especially in the presence of the 
operating surgeon.  Adequate macro photography can also be helpful.  This 
information should be adequately labeled and should accompany the explanted 
components.  This should facilitate the ability to differentiate between damaged 
regions caused in vivo and those caused during extraction. 
5. Collection of clinical history of the implant and patient 
Subject Information (data previously collected in Baseline CRF) 
• 
Subject Identification Number 
• 
Subject’s height and weight 
• 
Female/male  
• 
Date of birth 
• 
Number of previous surgeries prior to implantation of current device 
• 
Known metal sensitivities 
 
 

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Initial Surgery Details (data previously captured in the initial Operative CRF) 
• 
Original diagnosis 
• 
Date of Implantation 
• 
Hospital where implantation occurred 
• 
Surgeon name 
• 
Surgical site, left or right 
• 
Implanted components (serial numbers, size, and reference numbers) 
Revision/Explant Information (will be collected on revision/explant CRF) 
• 
Date of removal 
• 
Hospital where explant occurred 
• 
Surgeon name 
• 
Surgical site description 
• 
Subject’s height and weight at retrieval 
• 
Reasons for device removal (primary clinical diagnosis) 
• 
Tissue samples, descriptions or tissues, if applicable 
• 
Description of how the device was removed 
• 
Surgeon commentary/observations at revision, including assessment of bone 
quality if applicable 
• 
Other mitigating factors, if applicable 
Other Data Collected 
• 
Length of follow-up (automatically calculated in database) 
• 
Age at retrieval (automatically calculated in database) 
• 
Any complications occurring during the removal procedure (Complete AE CRF) 
• 
Any radiographs and/or other imaging available for analysis (Complete Imaging 
CRF) 
• 
Patient activity, experience with implant, and clinical performance (complete QOL 
forms) 
6. Collection of tissue and fluid samples near the implant, 
Collection of tissue and fluids will depend on how invasive is the revision, and 
particularly whether the stem will be removed, and also whether a glenoid 
component will be implanted. Surgeons shall not remove more fluid or tissue than 
those necessary for the revision.  Data will be collected as follows: 
 Whenever it’s possible and before opening articular capsule:  
(a) Extraction of synovial fluid by puncturing the joint (ideally 1ml, 1 ml of 
physiological saline can be injected and recovered),  
(b) extraction of 1ml blood (ideally decision made at the time of operation) each 
sample rapidly frozen and stored at - 20 °C to measure blood ion levels. 

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NOTE: Fluid samples should not be sent to Tornier.  Analysis should be completed 
at the hospital, as appropriate. 
 Extraction of a piece of articular capsule (minimum 1cm of length)  
 Extraction of a portion of cartilage (in the glenoid side) with a form of “carrot” 
whenever it’s possible (or another form), to analyze the bone cartilage interface 
and the cartilage status, by histological methods. 
 If important black color is detected (presence of wear particles), additional portions 
of tissues should be extracted and placed into a separate solution (see part 8.4) 
 If the stem is removed, a portion of bone at the interface with stem should be 
extracted to identify the bone status at this region.  
 A photographic record of the position of the removed bone and/or cartilage 
removed will be performed before retrieval. 
7.  Photographic record of the explanted device and tissues, 
 A photographic record of both the retrieved components (humeral head or 
stemmed component) and any tissues/bone dissections should be performed 
immediately after revision surgery.  This can be done after the scrub nurse has 
wiped the components free of excess blood and passed them from the sterile field- 
ideally onto a tray covered with a clean surgical towel.  A surgery label as used 
with tissue specimens (i.e., showing the patient ID/number, date, etc.) should be 
photographed at the beginning of the series and included in the photos where 
possible.  One photo should be taken at a magnification that allows all of the 
removed components to be viewed together, and subsequent photos should be 
taken of individual components at a magnification that allows their features to be 
clearly seen, including the laser markings and any obvious wear or damage to the 
parts.  The retrieved components should be photographed on both sides.   
8. Containing, labeling, cleaning, decontaminating, packaging and shipping of 
retrieved implant, tissue, or fluid samples, 
8.1. Labeling the explanted materials for future identification 
 
 Stem and head are laser etched, so there is no need to affix a label to it. 
Nevertheless, each component or tissue removed from the patient will be sealed 
in a container that is subsequently labeled with the following information: 
 Patient ID number 
 Date explanted 
 Surgeon name 
 Hospital name 
 
 

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8.2. Documentation 
 
 Documentation must accompany the explanted materials to assist Tornier with 
identification of the retrieved materials.  Please see Section 5 for additional 
information on what must be recorded and documented.  
 Documentation shall begin when the implant is recovered and continue until 
examination and analysis is complete.  
 Treat the documented information as Confidential. 
 The following procedure should be used for recording retrieval information: 
o Record the cleaning and sterilizing method used to decontaminate the 
material. Please see section 8.3 for details on how to perform these 
activities. 
o Record the name of the shipping service (i.e. postal service, courier, etc.), 
shipping number, date of shipment, and time of release. 
o If the surgical implant is to be stored prior to shipment, record the storage 
location. 
o The documentation shall reflect the names of all responsible individuals 
handling the implant during retrieval and preparation for shipping, as well 
as any activities performed in conjunction with its handling. 
8.3. Cleaning and Decontamination/Sterilization 
 
Clean and decontaminate/sterilize the explanted system component(s) recovered in 
accordance with your facility’s best and safe practices for analysis prior to shipment 
and examination by Tornier.  
The following cleaning and decontaminate/sterilize methods are recommended by 
Tornier for the individual system components: 
 Cleaning method: 
 Intense water rinse 
 70 % to 80 % aqueous ethanol or isopropanol rinse with subsequent 
ultrasonic treatment or proteolytic enzyme or 1:100 solution sodium 
hypochlorite 
 Decontaminating and sterilizing method of components and tissues:   
 When decontaminating/sterilizing the explanted components, they should 
be done so in a manner that does not alter features or surfaces which may 
be essential in determining failure modes.  In consequence, cold 
sterilization techniques are recommended.  The explanted components 
should be placed into separate plastic containers filled with 10% neutral 
buffered formalin to at least twice the volume of the implant.  The containers 

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must each have a standard surgical specimen label showing the medical 
record number, date of procedure, surgeon, and the patient number.  The 
member of the surgical staff who provides this container and receives the 
specimen should write the description of the individual specimens on the 
individual container (for example: ‘Removed Humeral Head’, or ‘capsule 
fragment 1 out of 2’).   
 Extracted tissues (bone, cartilage and capsule) should be placed into 
separate plastic containers filled with 10% neutral buffered formalin to at 
least twice the volume of the tissue.  If  important black color is detected 
(presence of wear particles), additional portions of tissues should be 
extracted and placed into glutaraldehyde, usually as a 2.5% solution in 
phosphate buffered saline). The containers must each have a standard 
surgical specimen label showing the medical record number, date of 
procedure, surgeon, and the patient number.  The member of the surgical 
staff who provides this container and receives the specimen should write 
the description of the individual specimens on the individual container.   
 A period of 24 hours is sufficient for explants with no or minimal tissue 
adherence, but specimens with substantial amounts of adherent bone (for 
example end-plate components), or tissue of a larger volume will require 
more time in formalin. Formalin does not adversely affect the subsequent 
analysis of the surface, so for all explants (tissue, implant), a permanent 
storage in formalin will be used to store and transport the samples.  
 Note: Other methods of sterilization such as autoclaving are forbidden as 
they might result in irreversible damage in the form of permanent adherence 
of residual blood or fluids, and will render adherent tissues unsuitable for 
subsequent histological analysis.   
 Care should be taken during any subsequent handing of the specimens to avoid 
damage to the parts such as rubbing the articulating surfaces together, dropping 
or knocking the parts or allowing tissue attached to the implants to dry out. 
8.4. Packaging and Shipping the explant for shipment 
 
Each retrieved component should be individually wrapped and stored in its own 
container, then placed in a larger container with all the other retrieved components. 
(i.e., do not place humeral head and flex stemmed component in the same bag or 
container.)  This will prevent damage to the explants, which can be difficult to 
distinguish from in situ damage. 
Packaging    

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 Place the cleaned and decontaminated/sterilized explanted component(s) or 
tissues (see method above) in a durable, primary container. 
 Securely seal the primary container. 
 Package the primary container in an outer shipping container using shock-resistant 
packing material. 
 Securely seal the outer shipping container. 
Labeling of the package 
• 
The inner and outer shipping containers shall bear a label with the name, address 
and telephone number of the sender. 
• 
The outer shipping container shall also contain a label, which instructs anyone 
handling the package to isolate the package upon discovery of damage and to 
notify the sender. 
• 
The outer package shall include all of the information required by Tornier (i.e. RMA 
number). 
• 
The package shall be shipped to Tornier at the following address:  10801 Nesbitt 
Ave South, Bloomington, MN  55437 (ATTN:  RMA Number XXXXX) 
• 
Call Tornier Clinical and advise them of the return shipping information. 
Documentation 
• 
Affix all packing slips, documents and correspondence with Tornier to the outer 
shipping container so that the receiving facility will not be required to open the 
package in order to identify its contents or intended receiver. 
9. Analysis of tissue and fluids 
9.1. Fluid analysis: 
Fluid (blood and synovial) analysis needs to be completed per the hospital standard 
procedures to assess for: debris, metal, abnormalities.  The following guidelines 
should be followed, if appropriate. 
For blood samples: 
Blood samples drawn from patients should be done using polypropylene syringes. The 
blood can be allowed to clot at room temperature and centrifuged for 30 minutes to 
separate serum and clot fractions. Blood may also be drawn in heparinized vacutainer 
tubes. The blood may be allowed to settle so as to isolate red and white cells, or be 
centrifuged at 400 g and plasma supernatant drawn off. Plasma is diluted at least 2ൈ 
in 1 % nitric acid. (ASTM standard F516-part 9.4.3.1) 

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Then to assess inflammation (depending of hospital), Erythrocyte sedimentation rate 
(ESR) could be performed. A blood sample is taken and put in a tube that contains a 
chemical to stop the blood from clotting. The tube is left to stand upright. The red blood 
cells (erythrocytes) gradually fall to the bottom of the tube (as a sediment). The clear 
liquid plasma is left at the top. The ESR measures the rate at which the red blood cells 
separate from the plasma and fall to the bottom of a test tube. The rate is measured 
in millimeters per hour (mm/hr). This is easy to measure as there will be a number of 
millimeters of clear liquid at the top of the red blood after one hour. 
If certain proteins cover red cells, these will stick to each other and cause the red cells 
to fall more quickly. So, a high ESR indicates inflammation.   
A quantification of the percentage of ionic metal may also be extracted from the blood 
test analysis with high resolution inductively coupled plasma mass spectrometry 
(HRICPMS), if available 
For synovial liquid: 
Digestion Protocol (ASTM Standard F561-13, part 11.4): 
- 
Mix 150 μL of 1M HEPES (pH=7.5), 6 μL of 1 M MgCl2, 75 μL of 0.5 M CaCl2, and 
2.8mL of synovial fluid for a total of 3 mL in a 50 mL siliconized blue capped tube. 
(In less than 2.8 mL of synovial fluid are available, add deionized water to a total 
volume of 2.8 mL.) Add 300 μL of dilute Hyaluronidase (0.05 % (g ⁄100 mL) 
Hyaluronidase, 0.1 MNaH2PO4 (pH 5.3), 0.15M NaCl) to the synovial fluid mix. 
- 
Incubate at 37ºC with a gyration of 250 rpm for 6 hours. Add 5μl of diluted 
Benzonase (that is, 5 μL of Benzonase in 50 μL of: 50 % glycerol, 0.02 M Tris HCl 
(pH=8.0), 0.002 M MgCl2, 0.02 M NaCl) to each sample. 
- 
Incubate at 37ºC with a gyration of 250 rpm overnight (total fluid 3.305 mL). 
- 
Follow the protocol established for the digestion and separation of the 
metal/ceramic particles (11.2.6, standard F561-13). Since synovial fluid does not 
contain EDTA as in simulator lubricant, the amount of calcium to be added should 
lead to 18 mmol/l rather than 40mmol/l as per the simulator extraction.  
Several stages of filtration may be necessary to effectively isolate the different 
particles of interest. 
The characterization and the quantification of wear particles can be performed over 
two different supports: silicon wafers used for scanning electron microscopy (SEM) 
analysis and TEM grids for transmission electron microscopy analysis.  Chemical 
analysis methods such as EDXA and FTIR could also be employed to determine the 
chemical nature of the particles. 
9.2. Macroscopic Examination of Tissues: 
 

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Record a gross pathologic description of extracted tissues, as to consistency and 
color, as seen by the naked eye. Record any differences between the implant-tissue 
interface and the tissues not in direct contact with the implant. Describe the specimen 
size either by dimensions or weight. 
Where appropriate and feasible, obtain photographic documentation of the explant 
and adjacent tissue, as well as a photographic record of subsequent dissections 
describing the edges tissues and indicating in which side the tissue rubbed against 
the implant. 
9.3.  Histological procedure  
 
The standard steps are: Fixation that preserves the tissue, Processing that 
dehydrates, clear and infiltrate the tissue with paraffin wax, Embedding that allows 
orientation of the specimen in a “block” that can be sectioned and is easy to store and 
handle, and Sectioning using a microtome to produce very thin sections that are 
placed on a microscope slide ready for staining and staining and diagnosis.  
These following procedures may be applicable for paraffin embedding, methacrylate 
embedding or other special procedures. 
9.3.1. Fixation:  
 
Tissues are fixed in 10% neutral buffered formalin (4% formaldehyde in phosphate 
buffered saline for light microscopy. For electron microscopy, the most commonly 
used fixative is glutaraldehyde. These fixatives preserve tissues or cells mainly by 
irreversibly cross-linking proteins. The main action of these aldehyde fixatives is to 
cross-link amino groups in proteins through the formation of methylene bridges (-
CH2-), in the case of formaldehyde, or by a C5H10 cross-links in the case of 
glutaraldehyde. This process, while preserving the structural integrity of the cells 
and tissue can damage the biological functionality of proteins, particularly 
enzymes, and can also denature them to a certain extent. This can be detrimental 
to certain histological techniques.  
9.3.2. Processing:  
 
For light microscopy, paraffin wax is most frequently used. Since it is immiscible 
with water, the main constituent of biological tissue, water must first be removed 
in the process of dehydration. Samples are transferred through baths of 
progressively more concentrated ethanol to remove the water. This is followed by 
a hydrophobic clearing agent (such as xylene) to remove the alcohol, and finally 
molten paraffin wax, the infiltration agent, which replaces the xylene. Paraffin wax 

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does not provide a sufficiently hard matrix for cutting very thin sections for electron 
microscopy. Instead, resins are used. Epoxy resins are the most commonly 
employed embedding media, but acrylic resins are also used, particularly where 
immunohistochemistry is required. Thicker sections (0.35μm to 5μm) of resin-
embedded tissue can also be cut for light microscopy. Again, the immiscibility of 
most epoxy and acrylic resins with water necessitates the use of dehydration, 
usually with ethanol. 
9.3.3. Embedding  
 
After the tissues have been dehydrated, cleared, and infiltrated with the embedding 
material, they are ready for external embedding. During this process the tissue 
samples are placed into molds along with liquid embedding material (such as agar, 
gelatin, or wax) which is then hardened. This is achieved by cooling in the case of 
paraffin wax and heating (curing) in the case of the epoxy resins. The acrylic resins 
are polymerized by heat, ultraviolet light, or chemical catalysts. The hardened 
blocks containing the tissue samples are then ready to be sectioned. Because 
Formalin-fixed, paraffin-embedded (FFPE) tissues may be stored indefinitely at 
room temperature, and nucleic acids (both DNA and RNA) may be recovered from 
them decades after fixation, FFPE tissues are an important resource for historical 
studies in medicine. 
After the sufficient period of fixation and processing (determined by the histological 
laboratory) tissues sections are deparaffinated in xylene for 5 min twice, and then 
rehydrated with absolute ethanol for 3 min, 95 % ethanol for 3 min, and then in 70 
% ethanol for 3 min. The sections are then placed in a methanol-hydrogen 
peroxide solution for 30 min to diminish the background level of peroxidase in the 
tissue. The sections are rinsed in water, next placed in buffered saline, and then 
the slide around the section is dried.  
9.4. Histological analysis 
9.4.1. Histopathological analysis 
 
Routine staining with hematoxylin and eosin (H & E) or toluidine blue are 
recommended for light microscopy of soft tissues and bone. Hematoxylin, a basic 
dye, stains nuclei blue due to an affinity to nucleic acids in the cell nucleus; eosin, 
an acidic dye, stains the cytoplasm pink. Uranyl acetate and lead citrate are 
commonly used to impart contrast to tissue in the electron microscope. This 
analysis allows to identify soft tissue damage/destruction via metallosis, i.e., the 
build-up of corrosion products in tissues, bony destruction (osteolysis), giant cell 
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9.4.2. Immunohistological analysis 
 
These procedures can be used for identifying specific cell types and extracellular 
matrix tissue responses to implantable materials and prosthetic devices, in 
particular  macrophage activity, white blood cell infiltration, blood cell death, and 
presence/absence of germinal centers.  This field is constantly changing, and 
therefore only one such approach is provided as an example. We are looking for 
Lymphoid populations (B and T lymphocytes) and histiocytic macrophage 
population. 
9.4.2.1. 
Lymphoid populations 
 
Typical markers chosen are for the presence of immunoglobulins on 
lymphocytes to indicate B cells or on monocytes/macrophages to indicate 
activation, the presence of CD2 markers to indicate immature T cells, the 
presence of CD3 markers to indicate mature T cells, and markers to indicate 
activated macrophages. Then we can go further by distinguishing the 
populations of B and T lymphocytes (CD3 or CD20 markers). After sectioning, 
the slide is then placed in a humidity chamber, covered with buffer, and the first 
antibody is added. This will be the antibody specific for the marker (for example, 
CD2) and will be either of mouse or rabbit origin. This is incubated overnight, 
then rinsed with buffer, drained, and the slide around the tissue dried. 
9.4.2.2. 
Histiocytic macrophage populations:  
 
We apply the same protocol using CD68 

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10. Analysis of retrieved components – Stage 1: visual analysis,  
General scheme of the retrieved components analysis:
Figure 8: Retrieved Component Analysis
implant arrival (in 
formaldehyde container)
1)AequalisTM Pyrocarbon Humeral Head 
dismounting and pull out measurements.
2)visual inspection on 
dissasembled components
3) No fretting / corrosion 
signs : cleaning
3') Fretting / corrosion signs : 
quantification of the products on both 
components
4) on Pyc bearing surface : 
surface roughness 
measurement
4') on CrCo double taper 
neck : CMM inspection
5) Gap measurement between Pyrocarbon 
bearing surface and CoCr double taper neck
6) Pyrocarbon bearing surface cross section and pyrocarbon 
coating aspect and thickness examination on SEM
7) conclusions

Note: Step 2 is a visual analysis, steps 1, 3, 3’, 4, 4’, and 5 are physical analysis, and 
step 6 is destructive analysis 
Step 1: AequalisTM Pyrocarbon Humeral Head dismounting and pull out measurements. 
If the stem has been removed in the same surgical procedure than the head (case of 
loosening) i.e. the head is still fixed on the stem, then the pull out resistance between the 
AequalisTM Pyrocarbon Humeral Head and the AequalisTM Ascend TM stem will be 
measured as follows: 
 
Figure 9: Head and Stem Pull Out Test  
 
 

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If the AequalisTM Pyrocarbon Humeral Head has been retrieved separately from the 
AequalisTM Ascend TM stem, or when the AequalisTM Pyrocarbon Humeral Head will have 
been dismounted from the AequalisTM  Ascend TM stem following the previous protocol, 
the pull out resistance between the Pyrocarbon bearing surface and the CrCo double 
taper neck will be measured as follows : 
 
 
Figure 10: Pyrocarbon Bearing Surface and CrCo Double Taper Neck Pull Out Test 
 
The curve load/displacement will be recorded.  Particular attention will be paid not to damage 
the components during dismounting, particularly in the area of contact between Pyrocarbon 
bearing surface and CoCr double taper neck.  
 
After pull out, the components are gently dried, with particular care to not touch area of 
possible fretting corrosion (area of contact between Pyrocarbon bearing surface and CoCr 
double taper neck) 
 
Step 2: General visual inspection of the components. 
The goal of this first step of visual inspection is to determine, before any further 
manipulation of the device, if there is the presence of wear, scratching, cracking or 
fretting/corrosion between Pyrocarbon bearing surface and CoCr double taper neck. The 
2 retrieved components (Pyrocarbon bearing surface and CoCr double taper neck) will 
be examined on all surfaces. For detailed exam mapping, the schematic images should 
include a number of views of the components, including top and bottom views, with clear 
identification of areas of interest, such articular wear, transitional wear zones, light 
scratching, heavy scratching, cracking, substrate (graphite) exposure or wear-through, 
embedded particles, impingement, corrosion of either articular or modular surface, 
contamination/discoloration/staining areas, backside wear, front face/rim wear, surface 
pitting, taper wear/corrosion, tribochemical layers, etc. The above schematic images 
should be accompanied by a series of SEM images of areas of interest, importantly, 

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showing the location of where the images were taken. When pictures show some deposit 
on the surface, EDX exam will be executed to determine what is the physical nature of 
this deposit.  
A particular attention will be paid to fretting-corrosion phenomenon, and the use of the 
scoring method described in Goldberg et al [1].  The grading will allow to graduate 
between 1 (none) to 4 (severe) the corrosion and fretting of the different parts as follows: 
- 
None (score 1): No visible corrosion observed.  No visible signs of fretting 
observed 
- 
Mild (score 2) : <30% of taper surface discolored or dull.  Single band or bands of 
fretting scars involving three or fewer machine lines on taper surface. 
- 
Moderate (score 3) : >30% of taper surface discolored or dull, or <10% of taper 
surface containing black debris, pits, or etch marks.  Several bands of fretting scars 
or single band involving more than three machine lines. 
- 
Severe (score 4) : >10% of taper surface containing black debris, pits, or etch 
marks.  Several band of fretting scars involving several adjacent machine lines, or 
flattened areas with nearby fretting scars. 
 
Five scores will be established: 
- 
One score for the morse taper of the CoCr double taper neck which was in 
connection with the stem (metal/metal connection); 
- 
One score for the other morse taper of the CoCr double taper neck (which was in 
connection with the Pyrocarbon bearing surface); 
- 
One score for the surface of the CoCr double taper neck which was in contact with 
the Pyrocarbon bearing surface (disk shaped surface); 
- 
One score for the surface of the Pyrocarbon bearing surface which was in contact 
with the CoCr double taper neck surface (disk shaped surface); 
- 
And one score for the female morse taper the Pyrocarbon bearing surface. 
 
For the contact between Pyrocarbon and metal, the philosophy of the score will be used, 
but slightly adapted because of the difference of material and thus the difference of 
phenomenon that can appear (wording slightly different as colored surface instead of 
discolored surface). 
Pyrocarbon bearing surface will thus benefit of 2 scores.  CoCr double taper neck will 
benefit of 3 scores.  All scores will be documented and reported with appropriate pictures. 
 
Parts being scored at 1 (no corrosion) will proceed to step 3, and parts scored from 2 to 
4 at even only one of their score will proceed to step 3’ for quantification and qualification 
of metallic deposits on the parts. 
 

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11. Analysis of retrieved components and records – stage 2: physical analysis, 
  
Step 3: Cleaning of parts having no fretting corrosion phenomenon. 
Parts not featuring signs of fretting will be cleaned by ultrasonic bath in alcohol for 15mn, 
for future physical exams (step 4). 
 
Step 3’: Quantification of the fretting corrosion deposits on the components. 
 
Parts being scored 2 to 4 at the fretting-corrosion scoring of step 2 will be treated as 
follows.   
 
The aim of this study is to quantify the metals residue that can be found on the two 
components of the AequalisTM Pyrocarbon Humeral Head after implantation. 
The metals to be quantified are those produced by the possible damage of the CoCr 
double taper neck material, and visualized by EDX probe at step 2, i.e. Cobalt, Chromium, 
Manganese, Nickel and Molybdenum. 
 
Each item is soaked in 50 ml of water and sonicated for 210 minutes, the solution is then 
diluted 1:2 and 1:10 to obtain values that fall into the range of the available standards for 
all the investigated metals. Solutions are evaluated by ICP-MS, and quantity of metal 
expressed in µg/component. 
 
Step 4: surface roughness measurement on Pyrocarbon bearing surface 
For implants that did not exhibited early loosening (<3 months), surface roughness 
measurements of the surface features of the Pyrocarbon bearing surface should include 
at least: average roughness (Ra), surface texture (Rz), maximum scratch height (Rp) and 
skewness (Rsk), plus be accompanied by close-up photographs for each measurement 
site to provide a visual indication of the amount of wear that took place and what wear 
processes were involved. At a minimum, surface roughness should be measured at sites 
of high polishing and obvious damage areas, i.e. (if applicable), 1) main wear zones, 2) 
areas of heavy scratching, 3) sites of impingement, 4) sites of corrosion, 5) sites of surface 
cracking, 6) sites of stripe wear, 7) backside wear and 8) coloration or staining. 
Note: pyrocarbon bearing surface not being of a simple geometry, the wear assessment 
will be performed by measurement of the gap value (see step 5) for the assessment of 
the wear in the morse taper and by cross section of the part (see step 6) in all possible 
wear area.   
 
Step 4’: CMM inspection on CrCo double taper neck 
 
For implants that did not exhibited early loosening (<3 months), then every effort should 
be made to estimate the total volumetric wear from the explanted CoCr double taper neck. 
A suggested technique includes a three-dimensional coordinate measuring machine 

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(CMM) to measure changes in component dimensions of both worn and unworn surfaces. 
Estimations of volumetric wear can then be determined using 3D modeling software. 
 
Step 5: Gap measurement between Pyrocarbon bearing surface and CoCr double taper 
neck 
 
Measurement of the Gap between Pyrocarbon bearing surface and CoCr double taper 
neck will be measured with the same or better accuracy than it had been measured before 
assembly of the parts in the clean room. Value obtained will be compared to the initial 
value recorded in the clean room. Any sign of limping or mismatch of the morse taper 
assembly will be recorded.  Note: the gap will be measured with the parts positioned in 
the same dial orientation than they were before disassembly 
12. Analysis of retrieved components – stage 3: destructive analysis, 
 
Step 6: Pyrocarbon coating aspect and thickness examination on  
After completion of all non-destructive tests and exams on both parts (AequalisTM 
Pyrocarbon Humeral Head and CoCr double taper neck), a cross section of the 
AequalisTM Pyrocarbon Humeral Head will be performed, perpendicular to the area of 
possible maximum wear. In case of doubt to situate this area, several cross sections will 
be performed. SEM pictures of this cross section will measure the PyC layer thickness, 
and compare it to the thickness of the layer right next to this contact area, in an area 
proven not be in contact. Thickness values will be compared, to calculate the possible 
worn thickness. 
13. Determination of the mode and cause of failure. 
Best efforts will be made to integrate all data given by the different exams to build a 
structured explanation of the mode and cause of fail. 
 
 

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14. Bibliography 
 
[1] J. Goldber, J. Gilbert, J. Jacobs, T. Bauer, W. Paprosky and S. Leurgans, "A multicenter 
retrieval study of the taper interfaces of modular hip prostheses," Clin Orthop Relat Res, no. 
401, pp. 149-164, 2002.