36mm CERAMAX® Ceramic Hip System PMA PAS STUDY: Short to Mid-Term Follow-up , New Study Subjects (Ceramic Hip System, Subjects Receive CERAMAX 36mm Ceramic Acetabular Bearing Insert That Articulates With a Ceramic Femoral Head for THA)
Phase: NA
Conditions: Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-Traumatic Osteoarthritis of Hip
Sponsor: DePuy Orthopaedics

NCT02096211

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PROTOCOL SIGNATURE PAGE 
 
I have read this protocol and agree to conduct this clinical investigation in accordance with the 
design and specific provisions outlined herein. 
 
I understand I am solely responsible to ensure the investigation is conducted in accordance with 
Good Clinical Practices, Declaration of Helsinki, applicable FDA regulations, local regulations, 
the signed agreement with DePuy Synthes, and with the protocol outlined herein.  
 
I will provide copies of the protocol and all pertinent information to all individuals responsible to 
me who will assist in the conduct of this study. I will discuss this material with them to ensure they 
are fully informed regarding the device and the conduct of the study.  
 
I will fulfill the requirements of my Institutional Review Board (IRB), or other oversight 
committee, to ensure complete and continual oversight of this clinical investigation.  
 
I will use an Informed Consent Document approved by DePuy Synthes and my reviewing 
oversight committee.  
 
I agree to report all information or data in accordance with the protocol and, in particular, I agree 
to report any serious adverse events as defined in this protocol to DePuy Synthes and my reviewing 
oversight committee. 
 
I agree to permit DePuy Synthes, FDA, the IRB/EC, or other regulatory authorities’ direct access 
to all records, including source data/documents, relating to the clinical investigation, whether 
paper-based or electronic data capture. 
 
The below signature confirms I have read and understood this clinical investigational protocol and 
its associated amendments or attachments, and will accept respective revisions or amendments 
provided by DePuy Synthes, Inc.  
  
 
 
PRINTED OR TYPED NAME 
 SIGNATURE 
 DATE 
 
  
  
Principal Investigator 
  
  
 
 
 
 
 
 
 

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1 
TABLE OF CONTENTS 
 
1 Table of Contents .................................................................................................................. 3 
2 Exhibits .................................................................................................................................. 5 
3 Table 1 Study Summary ...................................................................................................... 6 
4 Table 2: Subject Management Study Schedule ................................................................. 8 
5 Introduction .......................................................................................................................... 9 
6 Purpose .................................................................................................................................. 9 
7 Device Description ................................................................................................................ 9 
7.1 
The 36 mm CERAMAX® Ceramic Hip System consists of: ......................... 9 
7.2 
36 mm CERAMAX® Ceramic Acetabular Bearing Insert ............................ 9 
7.3 
PINNACLE Metal Outer Shell ....................................................................... 9 
7.4 
Ceramic Femoral Head ................................................................................. 10 
7.5 
Femoral Stem ............................................................................................... 10 
8 Study Design, IRB Review, Informed Patient Consent (IPC), Financial Disclosure ... 10 
8.1 
Study Design ................................................................................................ 10 
8.2 
Primary Endpoint ......................................................................................... 10 
8.3 
Primary Endpoint Justification ..................................................................... 10 
8.4 
Sample Size .................................................................................................. 11 
8.5 
Anticipated Number of Subjects with Minimum 5 Year Follow-up ............ 11 
8.6 
Treatment Assignment ................................................................................. 11 
8.7 
Secondary Endpoints .................................................................................... 12 
8.8 
Interim Analysis ........................................................................................... 12 
8.9 
Analysis Plan ................................................................................................ 12 
8.10 
Institutional Review Board ........................................................................... 13 
8.11 
Informed Patient Consent (IPC) and Authorization for Release of Medical 
Records ......................................................................................................... 13 
8.12 
Financial Disclosure ..................................................................................... 13 
9 Post Approval Study Plan .................................................................................................. 14 
9.1 
Subject Population ........................................................................................ 14 
9.2 
Indication for Use ......................................................................................... 14 
9.3 
Subject Eligibility ......................................................................................... 14 
9.4 
Inclusions: .................................................................................................... 14 
9.5 
Exclusions: ................................................................................................... 14 
9.6 
Recruitment Strategy .................................................................................... 15 
9.7 
Enrollment & Subject Identification Number .............................................. 15 
9.8 
Subject Evaluations and Follow-up .............................................................. 15 
9.9 
Table 3 Subject Evaluations. ........................................................................ 16 
9.10 
Table 4: Postoperative Visit Intervals .......................................................... 18 
10 Risk Analysis ....................................................................................................................... 18 
10.1 
Potential Adverse Events (AEs) ................................................................... 18 
10.2 
Potential Adverse Events (AEs) Associated with the CERAMAX® Ceramic 
Hip System ................................................................................................... 19 
10.3 
Table 5 Definitions of Adverse Events (AE) Types ..................................... 19 
10.4 
Definition of AE Severity ............................................................................. 22 

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10.5 
Adverse Event (AE) Reporting .................................................................... 22 
10.6 
Determination of Relationship to Device and/or Procedure ........................ 23 
10.7 
Minimization of Risk .................................................................................... 23 
11 Study Summary Statement ................................................................................................ 24 
12 Implants Retrievals ............................................................................................................ 24 
13 Clinical Monitoring ............................................................................................................ 24 
14 Reporting ............................................................................................................................. 24 
15 Publication Policy ............................................................................................................... 25 
16 Projected Timelines for Post approval Study .................................................................. 25 
16.1 
Overall Study Projected Timeline ................................................................ 25 
16.2 
Annual/Interim Reports Projected Timeline ................................................ 26 
 

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7.4 
Ceramic Femoral Head  
The 36 mm BIOLOX delta® ceramic femoral head components are manufactured from the same ceramic material 
as the acetabular bearing insert components. The femoral head is secured to the femoral stem component with an 
interlocking taper.  There are two taper sizes: 11/13 and 12/14 and these sizes correspond to the appropriate 
femoral stem.  The femoral head is available in several outer diameter sizes and multiple offsets; only 36 mm 
heads will be utilized in this PAS to match the inner diameter of the ceramic bearing insert. 
7.5 
Femoral Stem  
The stems with the 36 mm CERAMAX® device include the SUMMIT® POROCOAT®, Tri-Lock® Bone 
Preservation Stem (BPS) and the S-ROM® devices only. Refer to Exhibit K for a complete listing of permitted 
stems.  
 
8 
STUDY DESIGN, IRB REVIEW, INFORMED PATIENT CONSENT (IPC), FINANCIAL 
DISCLOSURE 
8.1 
Study Design 
This is a prospective, non-controlled, non-randomized, multicenter study of the 36 mm Ceramic on Ceramic 
(COC) device.  
A new enrollment cohort of a minimum of 170 subjects will be prospectively enrolled into the study.  Study sites 
will be comprised of both IDE study sites, as well as newly recruited sites.  These subjects will be seen for a pre-
op clinic visit at the time of consent, and then at 6 weeks, 1 year, 2 years, 3 years, 4 years, and a minimum of 5 
years. The purpose of the pre-op visit will be to obtain patient medical history and baseline information. At the 
post-op clinic visits the following information will be obtained:  a Harris Hip evaluation, radiographic evaluation, 
subject evaluation and adverse event information (if applicable).  The primary endpoint in this study is device 
survivorship at 5 years post-op. A minimum of 80% of enrolled subjects will be confirmed to either have a 
surviving implant or to have had a revision at a minimum of 5 years post-op with a clinical evaluation.  
For a given Subject, their study participation will end if they withdraw consent, as per PI decision, undergo a 
revision of either the acetabular shell and/or liner, are reported as deceased or when they have reached the final 
endpoint at 5 years.   
8.2 
Primary Endpoint 
Device survival at 5 years post-op is the primary endpoint in this study.  A revision is defined as the removal of 
any THA component(s), and device survival is defined as the lack of revision.  A 5-year Kaplan-Meier 
survivorship estimate of COC 36 mm implanted hips will be estimated.        
8.3 
Primary Endpoint Justification 
The maximum acceptable hazard of revision for the COC 36 mm system is assumed to be a constant 1% per year, 
that is, h(t) = 0.01. The survival function for this hazard is  
𝑆𝑆(𝑡𝑡) = 𝑒𝑒𝑒𝑒𝑒𝑒ቈ−නℎ(𝑢𝑢)𝑑𝑑𝑑𝑑
𝑡𝑡
0
቉= exp (−0.01𝑡𝑡), 
so at 5 years, a minimally acceptable level of survival is assumed to be 

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𝑆𝑆(10) = 𝑒𝑒𝑒𝑒𝑒𝑒[−0.05] = 0.951. 
It will be demonstrated that the Kaplan-Meier 5-year point estimate of survival is at, or higher than this minimally 
acceptable level of 95.1%. 
8.4 
Sample Size  
The sample size will be a minimum of 170 prospectively enrolled subjects.  This sample size will provide data 
upon which to obtain a 5-year survivorship estimate from newly enrolled subjects who did not participate in the 
COC36 IDE study.  The sample size of 170 subjects in this PAS is approximately the same sample size of COC36 
IDE investigational subjects, and hence will provide sufficient data on a new cohort of subjects to further support 
mid-term clinical success. 
 
The objective of this study is to obtain an estimate of device survivorship at 5-years post-operatively.  The enrolled 
170 enrolled subjects will provide a minimum of 136 subjects (80% of enrolled subjects) with 5-year follow-up.  
This will yield a 5-year survivorship estimate that has an approximate 3.6% margin of error. In particular, Peto’s 
estimate1 for the variance of a Kaplan-Meier survival estimate is 
𝑣𝑣𝑣𝑣𝑣𝑣൫𝑆𝑆̂(𝑡𝑡)൯= ൫𝑆𝑆̂(𝑡𝑡)൯
2൫1 −𝑆𝑆̂(𝑡𝑡)൯
𝑛𝑛(𝑡𝑡)
 
where 𝑆𝑆̂(𝑡𝑡) is the estimate of survival at time t and 𝑛𝑛(𝑡𝑡) is the number of unrevised subjects at risk (still being 
followed) at time, and t.  Hence, if it is assumed that the point estimate of survival is at a minimally acceptable 
level of 95.1% for subjects in this PAS, and there is a minimum of 136 subjects (80% of enrolled subjects) at 5-
years post-operatively upon which this estimate is based, then an estimate for the variance of the Kaplan-Meier 
survival estimate at 5 years is 
𝑣𝑣𝑣𝑣𝑣𝑣ൣ𝑆𝑆̂(5)൧=
[0.951]2(0.049)
136
= 0.00034 , 
and a two-sided 95% confidence interval margin of error for survival at 5 years is anticipated to be approximately 
1.96 ∗√0.00034 = 3.6%.   
A sample size of 170 enrolled subjects is therefore justified in order to obtain a 3.6% margin of error on a 5 year 
survivorship estimate. 
8.5 
Anticipated Number of Subjects with Minimum 5 Year Follow-up 
A minimum of 80% of enrolled subjects (136 subjects) will be confirmed to either have a surviving implant or to 
have had a revision at a minimum of 5 years post-op with a clinical evaluation. 
 
8.6 
Treatment Assignment 
The 36 mm COC device is the only device configuration of interest in the study. 
 
1 Cantor, A. Estimates of the Variance of the Kaplan-Meier Estimator. In: Extending SAS® Survival Analysis Techniques 
for Medical Research. 2nd ed., Cary NC: SAS Institute, 2003:24.  
 

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8.7 
Secondary Endpoints  
Secondary endpoints include Harris Hip score and sub-score means, radiographic evaluations, device 
survivorship, and adverse event outcomes at each protocol defined post-op interval.  Cumulative results of these 
endpoints will be reported in each interim PAS report to FDA.     
8.8 
Interim Analysis  
There are no planned interim analyses for the purpose of terminating the study early.  However, some statistical 
analyses may be performed for conference presentations or abstracts prior to the primary endpoint being reached.  
 
Interim analyses of the primary and secondary endpoints will be carried out for each interim PAS report to FDA. 
8.9 
Analysis Plan  
At the time of each interim PAS report, the following analyses will be presented for all subjects combined, as 
well as separately for each individual stem type that is represented in the PAS, and also separately for each 
individual cup type that is represented in the PAS:   
• Baseline summary statistics will be calculated for age, weight, BMI, race, ethnicity and pre-op Harris Hip 
Scores for both cohorts. The proportion of each gender will be calculated.  
• Harris Hip score summary statistics and change from baseline statistics will be reported for each protocol 
defined post-op visit interval.  These will be provided for total Harris Hip score as well as the Harris Hip 
sub-scores (pain, function, activity, deformity, and range of motion). These will be provided for total 
Harris Hip score as well as the Harris Hip sub-scores.  Results will be presented overall, as well as stratified 
by obesity (non-obese vs. obese) according to BMI (subjects with BMI < 30 and with BMI ≥ 30, 
respectively)2. 
• Subject-reported outcomes will be reported for each protocol defined post-op visit interval. 
• Radiographic analysis will be reported for each protocol defined post-op visit interval.  
• Tabular displays of all cumulative reported adverse events will be provided by adverse event, as well as 
by category (intraoperative, postoperative-operative site, systemic, and overall).  Tables will also be 
provided of adverse events over time. 
• A Kaplan-Meier survivorship analysis will be provided, with device survivorship as a function of post-op 
time.   A proportional hazards model will be provided, in which device survivorship is a function of post-
op time, and with BMI (at the time of index surgery) as a covariate.  Implant survival will be reported 
over time where greater than 40 hips are still at risk of revision.   
• For Subjects that are not able to return to clinic at the 3- or 4-year interval, device survivorship information 
will be obtained through telephone interviews and will be utilized in the Kaplan-Meier analysis of device 
survivorship for the primary endpoint analysis in the study. 
 
 
2 Obesity is defined as BMI ≥ 30 According to the World Health Organization: 
http://www.who.int/mediacentre/factsheets/fs311/en/ 

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8.10 Institutional Review Board 
Prior to enrolling subjects into the study, each participating Investigator will be required to obtain approval from 
the reviewing institutional review board (IRB) at each institution where the study will be conducted. It is the 
Investigator’s responsibility to submit and obtain IRB approval of the study plan, the Informed Patient Consent 
form (IPC), and any relevant study related information. 
 
Revisions or amendments to the study plan and/or the IPC form that affect the scientific soundness of the post-
approval study or the rights, safety or welfare of the participating subjects require approval by the reviewing IRB 
and the study sponsor prior to being implemented.  
8.11 Informed Patient Consent (IPC) and Authorization for Release of Medical Records 
An informed patient consent must be obtained for all subjects in person prior to enrollment into this 36 mm COC 
Post-Approval Study.  Subjects who agree to participate will complete an IRB-approved IPC that documents his 
or her willingness to take part in this post-approval study.  Each potential subject will have the nature and the 
purpose of this clinical investigation explained to him or her by the Clinical Investigator or another member of 
the investigative team at the site.  The investigator will explain the following features of the study to the patient 
thoroughly and will offer to answer any questions the patient may have. 
• The purpose of the study 
• Possibility of failure and subsequent treatment(s) 
• Alternative procedures 
• Requirements of the study (follow-up visits) 
• The plan to perform retrieval analysis in the event of an explanted device 
• A modest payment may be provided to cover subject travel expenditures associated with study 
participation to 5-years. 
Prior to entry into this clinical investigation the patient must give voluntary, written informed patient consent to 
participate by signing the IPC.  A copy of the IPC is to be provided to the subject.  A study subject is enrolled 
once they have signed the IPC and had the study device implanted. 
8.12 Financial Disclosure 
Each Investigator participating in the study will complete a financial disclosure form at the beginning of the study 
and then per DePuy Synthes’ policy thereafter. Per FDA requirements, an additional financial disclosure must be 
completed one year after the study has concluded. 
 
 
 
 

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3. The presence of any known neoplastic (tumor-causing) or metastatic (spread of cancerous cells) 
disease 
4. Significant neurologic or musculoskeletal disorders or diseases that may adversely affect gait, weight 
bearing or postoperative recovery (e.g., muscular dystrophy, multiple sclerosis) 
5. Presence of highly communicable disease(s) that may limit follow-up (e.g., immuno-compromised 
conditions, hepatitis, active tuberculosis, etc.) 
6. Any condition that may interfere with postoperative recovery (e.g., Paget’s disease, Charcot’s disease) 
7. Inadequate bone stock to support the device (e.g., severe osteopenia or osteoporosis) 
8. Poor skin coverage around the hip joint 
9. Use in patients with known allergies to the implant materials 
10. Marked atrophy (muscle and/or tissue loss) or deformity in the upper femur such as a birth defect 
affecting the leg bones. 
11. Inflammatory degenerative joint disease (e.g., rheumatoid arthritis) 
12. Subject has participated in an IDE/IND clinical investigation, other than the COC28/COC36 IDE or 
PAS for their contralateral hip, with an investigational product in the last three months. 
13. Subject is currently involved in a personal injury litigation, medical-legal or worker’s compensation 
claims. 
14. Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability 
to comply with protocol procedures and/or subject-completed questionnaires. 
15. The Subject is a woman who is pregnant or lactating. 
16. The Subject has a medical condition with less than 2 years of life expectancy. 
9.6 
Recruitment Strategy 
Sites will be recruiting potential study subjects from their population of primary total hip arthroplasties.  Sites 
will provide screening/enrollment logs to the Sponsor so that the Sponsor can monitor progress and reallocate 
cohorts as needed.   Sites will be instructed to begin actively recruiting all subjects upon receipt of the IRB 
approval letter.  Screening results are documented on the screening and enrollment log.   
9.7 
Enrollment & Subject Identification Number 
A study subject is enrolled when they have met eligibility criteria, been consented and had the THA procedure 
and study device implanted per protocol.  Once enrolled, the site assigns the subject ID number which is 
comprised of a two-digit site code followed by a 4- digit subject specific code.  For example, the first three 
enrolled subjects at site #06 would be: 06-0401, 06-0402, 06-0403.   
9.8 
Subject Evaluations and Follow-up 
Diagnostic, demographic and operative information and clinical follow-up for each enrolled Subject will be 
documented on case report forms which have been developed specifically for this study.  Examples of the case 
report forms for this post-approval study are provided in Exhibit A.   The “Status” case report form (CRF) is 
completed for all subjects to identify which protocol each subject is participating. Details of subject evaluations 
are summarized in Table 3 below.  

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• Temporary or permanent nerve damage resulting in pain or numbness of the affected limb; 
• Undesirable shortening or lengthening of the limb; 
• Traumatic arthrosis of the hip from intraoperative positioning of the extremity; 
• Cardiovascular disorders including venous thrombosis, pulmonary embolism, or myocardial infarction; 
• Temporary or permanent neuropathies; 
• Delayed wound healing; 
• Infection; 
• Osteolysis;  
• Fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any 
of which may require a second surgical intervention or revision; 
• Periarticular calcification or ossification, with or without impediment to joint mobility; 
• Inadequate range of motion due to improper selection or positioning of components, by femoral 
impingement, and periarticular calcification; and 
• Death. 
 
These possible AEs are not unique to the CERAMAX® Ceramic Hip System and, as stated above, may occur with 
any total joint replacement surgery. 
10.2 Potential Adverse Events (AEs) Associated with the CERAMAX® Ceramic Hip System 
The most commonly reported adverse events related to the DePuy Synthes CERAMAX® Ceramic Total Hip 
System are: 
• Wear of the ceramic acetabular components has been reported following total hip replacement.  Higher 
rates of wear may be initiated by particles of cement, metal, or other debris that can cause abrasion of the 
articulating surfaces.  Higher rates of wear may shorten the useful life of the prosthesis, and lead to early 
revision surgery to replace the worn prosthetic components.   
• While rare, fatigue fracture of the prosthetic component can occur as a result of improper assembly, 
trauma, strenuous activity, improper alignment, or duration of service. 
• Component dissociation. 
• Breakage or chipping of the ceramic femoral head and/or ceramic acetabular insert. 
  
There are no additional risks to the subject associated with participation in this study.  The evaluations included 
in the study are considered to be the standard of care for following total hip replacement patients.  Likewise, there 
is no personal benefit to the subject for participation in this study.  However, data collected in this study will 
contribute to the safety profile of this Ceramic on Ceramic articulation. 
10.3 Table 5 Definitions of Adverse Events (AE) Types 
For this protocol, the term “expected’ will be synonymous with the term “anticipated” and “unexpected” will by 
synonymous with “unanticipated”.  

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o required 
inpatient 
hospitalization 
or 
prolongation of existing hospitalization, or 
o resulted in medical or surgical intervention to 
prevent life threatening illness or injury or 
permanent impairment to a body structure or 
a body function. 
o led to fetal distress, fetal death or a congenital 
abnormality or birth defect. 
• Other serious important medical events. Report when 
the event does not fit the other outcomes, but the 
event may jeopardize the patient and may require 
medical or surgical intervention (treatment) to 
prevent one of the other outcomes.  
Examples of procedure related serious AEs (SAEs) may 
include: stiffness requiring manipulation of the hip under 
anesthesia, dislocation of hip requiring closed reduction, 
Deep Vein Thrombosis (DVT) without hospitalization.   
Examples of device related SAEs may include 
radiolucent lines around the femoral component or 
device dislocation.  
Unexpected/Unanticipated Adverse 
Device Effect (UADE)  
Is defined as any serious adverse effect on health or 
safety, or any life-threatening problems, 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 Clinical Investigation Plan, 
or application, or any other unanticipated serious 
problem associate with a device that relates to the rights, 
safety, or welfare of Subjects. A UADE will not be listed 
in the Instructions for Use (IFU).  
 
In the event of a UADE or serious adverse device effect, 
the Investigator should institute appropriate therapeutic 
and follow-up measures in accordance with good 
medical practice and notify the local IRB/EC.  The 
Investigator must document follow-up treatment in the 
“comment” section of the AE eCRF.  A full written report 

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of the event must be forwarded to DePuy Synthes within 
10 working days of the discovery. 
 
DePuy Synthes must notify FDA, all reviewing 
IRB/REB/EC’s 
and 
all 
participating 
Clinical 
Investigators of all UADEs within 10 working days of 
first receiving notice of the event.  In addition, the event 
will be reported to the DePuy Synthes Complaint 
Handling Unit (CHU) for investigation. 
Device Deficiencies  
Are defined as in adequacy of a medical device with 
respect to its identity, quality, durability, reliability safety 
or 
performance. 
Device 
deficiencies 
include 
malfunctions, use errors and inadequate labeling. Device 
deficiencies should institute appropriate therapeutic and 
follow-up measures in accordance with good medical 
practice and notify the IRB/EC as applicable.  The 
Investigator must document follow-up treatment of the 
AE and the Sponsor will report the event to the DePuy 
Synthes 
Complaint 
Handling 
Unit 
(CHU) 
for 
investigation. 
10.4 Definition of AE Severity 
An AE may be: 
• Mild: Easily tolerated and transient in nature with minimal or no impairment of normal activity. 
Intervention is not indicated. Clinical or diagnostic observations only and no impairment of normal 
activity.  
• Moderate: Poorly tolerated, sustained and interferes with normal activity and requires medical attention. 
Intervention is either noninvasive or not indicated. Activities of daily living can be sustained.  
• Severe: Poorly tolerated, requires intervention and significantly affects activities of daily life; or places 
the Subject at immediate risk or harm.  
10.5 Adverse Event (AE) Reporting 
The definition of an AE is provided above in Table 5. Pre-existing medical conditions or symptoms reported 
prior to the surgical event are to be recorded as part of the medical history and not be recorded/reported as AEs. 
The only exception would be in the event there is an exacerbation of a pre-existing medical condition or 
symptom(s) in the post-operative time frame, then an AE must be reported.   
 
A record of each AE, except for those anticipated AEs listed in Exhibit L, including details of the AEs are 
reported beginning from surgery and until Subject participation has ended (study completed, or consent 
withdrawn). Study sites have two (2) weeks from when they become aware of AEs to inform the Sponsor via the 

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AE CRF. If unable to enter the AE CRF you must contact the Sponsor directly or your Clinical Research Associate 
(CRA) to report.  
 
AEs must be followed to resolution, or until the study completion or consent withdrawal. When a Subject ends 
participation in the study (either completion or consent withdrawal) AEs must be reviewed and designated, if 
applicable, as “resolved” and an end date provided. If AEs are not resolved at the end of a Subject’s participation, 
they will be considered ongoing.  
 
An AE should be reported for each AE – meaning, if edema and bleeding occur secondary to a fall there will be 
two (2) AEs reported that can be attributed to a fall. Subjects should be encouraged to report AEs spontaneously 
and may volunteer AE information at any time. At each evaluation, the Subject should be asked if any AEs have 
occurred since their last evaluation.   If an event occurs at an outside institution, the Investigator should attempt 
to obtain, if possible, required AE information.  
 
The Investigator will record the nature, severity, treatment and outcome of the AE, and will determine their 
association to the device and/or the study procedure (see Section 10.6 below).  
 
All UADEs, SADEs and SAEs, defined in Table 5 above, that occur during this investigation must be reported 
by the Investigator no later than 72 hours from the time when the Investigator is aware of the event via the AE 
CRF. If unable to enter the AE CRF you must contact the Sponsor directly or your CRA to report.  
In the event of a UADE the investigator should institute appropriate therapeutic and follow-up measures in 
accordance with good medical practice and notify their IRB/EC.  The investigator must document follow-up 
treatment in the “comment” section of the AE CRF.  A full written report of the event must be forwarded to 
DePuy Synthes within 10 working days of the discovery. 
 
DePuy Synthes must notify FDA, all reviewing IRB’s and all participating clinical investigators of all UADEs 
within 10 working days of first receiving notice of the event.  In addition, the event will be immediately and 
electronically reported to the DePuy Synthes Complaint Handling Unit (CHU) for investigation. 
10.6 Determination of Relationship to Device and/or Procedure 
The determination whether the AE is related to the device and/or procedure will be based upon whether a causal 
relationship between the device or procedure and the AE a reasonable possibility is, i.e., the relationship cannot 
be ruled out. A causal relationship cannot be ruled out if, in the medical judgement of the Investigator, the effect 
follows a reasonable temporal association with the use of the device and/or is confirmed by the improvement of 
the effect upon discontinuation of the clinical use of the device, and/or the effect is not reasonably explained by 
the Subject’s clinical state.  
 
Device related AEs will be reviewed by DePuy Synthes and reported, if applicable, to the appropriate regulatory 
body.  
10.7 Minimization of Risk 
Only trained orthopaedic surgeons with expertise in treating total hip conditions will participate in this study.  
 
Investigators should refer to the instructions for use (package insert, Exhibit H) for additional information and 
reference the surgical technique (Exhibit D).  

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The Sponsor will further minimize the identified and/or emergent risks throughout the study, by reviewing the 
reported complications and adverse effects. All AEs, SAEs, ADEs, SADEs and UADEs will be reviewed and 
evaluated by the Medical Monitor assigned to this study.  
11 STUDY SUMMARY STATEMENT 
In summary, this PMA Post-Approval Study for the 36 mm CERAMAX® Ceramic Hip System will support short 
and mid-term safety and performance with an expanded pool of clinical investigators.  The newly enrolled 
subjects will expand information contained in the original PMA submission by supporting survivorship at 5 years 
post-op. 
 
For a given subject, their study participation will end if they withdraw consent, as per PI decision, undergo a 
revision of either the acetabular shell and/or liner, are reported as deceased or when they have reached the final 
endpoint at 5 years.   
12   IMPLANTS RETRIEVALS 
Any prosthesis that may be made available because of a removal or revision surgery or subject death will be 
submitted for detailed evaluation. A protocol for device explanation and retrieval analysis is included (Exhibit 
M).   
 
If the implant is known to be available, the sponsor will encourage the investigator to preserve the prosthesis 
alone, or, in the event of a death, if possible, provide the excised hip joint with the implant in place.  
 
Retrieval analysis will be completed by one or more independent reviewers as outlined in the Exhibit M.  In 
addition, DePuy Synthes and/or CeramTec may perform analyses, as appropriate. 
13 CLINICAL MONITORING 
Monitoring activities will follow the Sponsor standard operating procedures (SOPs), applicable FDA regulations 
and good clinical practices (GCPs).  Given that this is a regulated study and the level of risk to Subject safety and 
data integrity, and criticality of ensuring compliance, monitoring will include onsite monitoring visits. Remote 
monitoring may be conducted if deemed appropriate by the Clinical Study Lead and Clinical Operations lead 
(e.g., if sites have not enrolled (consented) any Subjects).   
14 REPORTING  
Reports of this study will be prepared according to the Guidance for Industry and FDA Staff: Clinical Data 
Presentations for Orthopaedic Device Applications.   
 
Per the Guidance for Industry and FDA Staff- Procedures for Handling Post-Approval Studies Imposed by 
PMA Order   
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm0710
13.pdf), the applicant will provide a report to the FDA every 6 months for the first 2 years following device 
approval and annually thereafter until the end of the study (see Section 16.2). 

p. 25 
 
Confidential 
DePuy Synthes  
May 11, 2020    
CIP#12017 Revision D  
The reports will include: 
• A complete listing of all sites and IRBs.  
• Enrollment updates (during enrollment) – screening/recruitment logs from all sites 
• Site follow-up compliance to clinical investigation plan,  
• Clinical Results- Overall Harris Hip Scores and Harris Hip sub-scores (pain, function, activity, deformity, 
and range of motion) 
• Radiographic Results 
• Safety Summary- documentation and compilation of all adverse events 
• Survivorship at each year post-operatively for which there are sufficient subjects to compute survivorship 
15 PUBLICATION POLICY  
All manuscripts of data obtained from this clinical investigation will be reviewed and approved by the sponsor, 
and each author, prior to any submission. And, current and applicable Medical Device & Diagnostic (MD&D) 
Publication Policy will be followed.    
 
DePuy Synthes will require a written agreement for any external author(s) prior to initiating any publication. All 
authors must disclose financial or personal affiliations that could be considered a conflict of interest. 
16 PROJECTED TIMELINES FOR POST APPROVAL STUDY 
16.1 Overall Study Projected Timeline 
The anticipated duration of this investigation is approximately seven years from the time of study initiation. 
• It may take up to a minimum of 2 years from the time of study initiation to enroll new subjects.  
• Each subject will be followed until they have completed their minimum 5 year follow-up. 
All timeline information is reflected as “deltas” compared to previous column.