Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System (Implant and Instrumentation) - A Retrospective Consecutive Series Study
Conditions: Acetabulum Fracture, Pelvic Ring Fracture
Sponsor: Zimmer Biomet

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 1 of 39 
Post-market Clinical Follow-up Study to Provide Safety, Performance 
and Clinical Benefits Data of the Zimmer® Reconstruction System 
(Implant and Instrumentation) - A Retrospective Consecutive Series 
Study 
 
Study Type: Post-market Clinical Follow-up 
Protocol Number: MDRG2017-89MS-99T 
NCT05215626 
Protocol Version: Revision 1.1 
Protocol Date: 02 JULY 2021 
Region: EMEA 
STUDY SPONSOR 
Zimmer GmbH 
Clinical Affairs 
Zählerweg 4 
CH-6300 Zug 
Switzerland 
+41 (0)58 854 80 00 
 
CONFIDENTIAL - This document contains confidential information belonging to Zimmer Biomet except as 
otherwise agreed to in writing, by accepting or reviewing this document, you agree to hold this information in 
confidence and not distribute or disclose it to others (except where required by applicable law) or use it for 
unauthorized purposes.  In the event of any actual or suspected breach of this obligation, Zimmer Inc. must be 
promptly notified.  Duplication and distribution of this document in any form or shape requires prior approval 
from Zimmer Biomet.distribution of this document in any form or shape requires prior approval from Zimmer Biomet. 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 2 of 39 
Table of Contents 
1 
DOCUMENT HISTORY .......................................................................................................................................... 5 
2 
CONTACT INFORMATION/LIST OF INVESTIGATORS .............................................................................................. 6 
3 
ABBREVIATIONS ................................................................................................................................................. 8 
4 
STUDY SYNOPSIS............................................................................................................................................... 10 
5 
DATA COLLECTION OVERVIEW .......................................................................................................................... 14 
6 
INTRODUCTION AND PURPOSE ......................................................................................................................... 15 
7 
STUDY DEVICE INFORMATION ........................................................................................................................... 15 
7.1 
STUDY DEVICE .........................................................................................................................................................15 
7.2 
DEVICE SCOPE .........................................................................................................................................................16 
7.3 
INSTRUMENTATION ..................................................................................................................................................18 
7.4 
ANCILLARY DEVICES ..................................................................................................................................................18 
7.5 
COMPATIBILITY ........................................................................................................................................................19 
7.6 
ACCOUNTABILITY OF DEVICES ......................................................................................................................................19 
8 
STUDY POPULATION ......................................................................................................................................... 19 
8.1 
INCLUSION CRITERIA .................................................................................................................................................19 
8.2 
EXCLUSION CRITERIA .................................................................................................................................................19 
9 
STUDY OBJECTIVES ........................................................................................................................................... 20 
10 
STUDY DESIGN AND ENDPOINTS ....................................................................................................................... 20 
10.1 
DISEASE/CONDITION BEING TREATED ..........................................................................................................................20 
10.2 
NUMBER OF SITES AND REGIONS .................................................................................................................................20 
10.3 
NUMBER OF CASES AND MAXIMUM ENROLLMENT PER INVESTIGATION SITE ........................................................................20 
10.4 
PARTICIPATING INVESTIGATORS AND ROLES (IF APPLICABLE) .............................................................................................21 
10.5 
STUDY DESIGN .........................................................................................................................................................21 
10.6 
EC APPROVAL .........................................................................................................................................................21 
10.7 
TYPE AND TIMING OF OBSERVATIONS ...........................................................................................................................21 
10.8 
PRIMARY AND SECONDARY ENDPOINT ..........................................................................................................................21 
10.8.1 
Primary Endpoint ........................................................................................................................................21 
10.8.2 
Secondary Endpoint ....................................................................................................................................21 
10.9 
STUDY HYPOTHESIS ..................................................................................................................................................21 
10.10 
SINCE THIS STUDY IS AN OBSERVATIONAL STUDY NO HYPOTHESIS IS USED IN THE STUDY. FINANCING OF THE STUDY ..................22 
10.11 
DEFINITION OF COMPLETION OF THE STUDY ..............................................................................................................22 
11 
STUDY PROCEDURES ......................................................................................................................................... 22 
11.1 
STUDY PARTICIPATION ..............................................................................................................................................22 
11.2 
INFORMED CONSENT ................................................................................................................................................22 
11.3 
INFORMATION ON DATA HANDLING AND PROCESSING (GDPR NOTICE) ..............................................................................22 
11.4 
STUDY LOGS ............................................................................................................................................................22 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 3 of 39 
11.4.1 
Subject Screening Log .................................................................................................................................22 
11.4.2 
Subject Identification Log ...........................................................................................................................22 
11.5 
DETERMINATION OF ELIGIBILITY AND ENROLLMENT .........................................................................................................22 
11.6 
PRE-OPERATIVE ASSESSMENT .....................................................................................................................................23 
11.7 
SURGICAL TECHNIQUES .............................................................................................................................................23 
11.8 
SURGICAL/IMMEDIATE POST-OPERATIVE ASSESSMENT ....................................................................................................23 
11.9 
FOLLOW-UP PROCEDURES..........................................................................................................................................23 
11.10 
MINIMIZATION OF LOSS TO FOLLOW-UP ...................................................................................................................24 
11.11 
RADIOGRAPHIC DEFINITIONS AND METHODS .............................................................................................................24 
11.12 
RECOMMENDED REVISION PROCEDURE ....................................................................................................................24 
11.13 
EXPLANT PROCEDURE ...........................................................................................................................................24 
12 
REPORTING ....................................................................................................................................................... 25 
12.1 
ACTIVITIES REQUIRED PRIOR TO INITIATION OF THE STUDY ...............................................................................................25 
12.1.1 
Clinical Trial Agreement (CTA) and Financial Arrangements ......................................................................25 
12.1.2 
Ethics Committee Protocol Approval ..........................................................................................................25 
12.1.3 
Clinicaltrials.gov Registration .....................................................................................................................25 
12.2 
CLINICAL DATA COLLECTION/SUBMISSION ....................................................................................................................25 
12.2.1 
Summary of Data Collection .......................................................................................................................25 
12.2.2 
Data Submission .........................................................................................................................................26 
12.2.3 
Quality Assurance of Data ..........................................................................................................................26 
12.2.4 
Patient Privacy and Identification ..............................................................................................................26 
12.2.5 
Data Management .....................................................................................................................................26 
12.3 
REPORTING REQUIREMENTS .......................................................................................................................................26 
12.3.1 
Investigator Reporting Responsibilities ......................................................................................................26 
12.3.2 
Retention of Records ..................................................................................................................................27 
12.4 
MANAGEMENT OF INTERCURRENT EVENTS ....................................................................................................................27 
12.4.1 
Failure to Obtain Informed Consent and/or GDPR notice ..........................................................................27 
12.4.2 
Revision ......................................................................................................................................................27 
12.4.3 
Investigator Withdrawal .............................................................................................................................27 
12.4.4 
Subject Withdrawal ....................................................................................................................................27 
12.4.5 
Lost to Follow-up ........................................................................................................................................27 
12.4.6 
Protocol Deviations .....................................................................................................................................27 
12.4.7 
Study Termination ......................................................................................................................................28 
12.4.8 
Adverse Events ............................................................................................................................................28 
13 
SAFETY MANAGEMENT – MEDICAL EVENTS/ADVERSE EVENTS .......................................................................... 29 
13.1 
CLASSIFICATION OF THE EVENT....................................................................................................................................29 
13.1.1 
Adverse Event (AE) ......................................................................................................................................29 
13.1.2 
Serious Adverse Event (SAE) .......................................................................................................................29 
13.1.3 
Serious Health Threat .................................................................................................................................29 
13.1.4 
Adverse Device Effect (ADE) .......................................................................................................................30 
13.1.5 
Serious Adverse Device Effect (SADE) .........................................................................................................30 
13.1.6 
Unanticipated Serious Adverse Device Effect (USADE) ...............................................................................30 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 4 of 39 
13.1.7 
Device Deficiency (DD) ................................................................................................................................30 
13.2 
CAUSALITY ASSESSMENT (RELATION TO DEVICE) ............................................................................................................30 
13.2.1 
Not Related .................................................................................................................................................31 
13.2.2 
Possible (Uncertain) ....................................................................................................................................31 
13.2.3 
Probable .....................................................................................................................................................31 
13.2.4 
Causal Relationship (Definitely related) .....................................................................................................31 
13.3 
REVIEW OF REPORTED EVENTS ....................................................................................................................................31 
13.4 
INTENSITY OF SYMPTOMS ..........................................................................................................................................31 
13.4.1 
Mild ............................................................................................................................................................31 
13.4.2 
Moderate ....................................................................................................................................................32 
13.4.3 
Severe .........................................................................................................................................................32 
13.5 
OUTCOME DEFINITIONS ............................................................................................................................................32 
13.5.1 
Resolved......................................................................................................................................................32 
13.5.2 
Resolved with Sequelae ..............................................................................................................................32 
13.5.3 
Resolving* ..................................................................................................................................................32 
13.5.4 
Not Resolved* .............................................................................................................................................32 
13.5.5 
Fatal* ..........................................................................................................................................................32 
13.5.6 
Unknown* ..................................................................................................................................................32 
14 
MONITORING ................................................................................................................................................... 33 
15 
RISK ANALYSIS .................................................................................................................................................. 33 
15.1 
GENERAL ................................................................................................................................................................33 
15.2 
INDEMNIFICATION ....................................................................................................................................................34 
16 
STATISTICAL METHODS ..................................................................................................................................... 34 
16.1 
SAMPLE SIZE CALCULATION ........................................................................................................................................34 
16.2 
GENERAL STATISTICAL METHODS ................................................................................................................................34 
17 
QUALITY CONTROL & QUALITY ASSURANCE ...................................................................................................... 35 
18 
SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION ................................................ 35 
19 
VULNERABLE POPULATIONS (AS APPLICABLE) ................................................................................................... 36 
20 
AMENDMENTS / MODIFICATIONS TO THE CLINICAL INVESTIGATION PLAN ........................................................ 36 
21 
PUBLICATION POLICY ........................................................................................................................................ 36 
22 
SIGNATURES ..................................................................................................................................................... 37 
23 
REFERENCES ..................................................................................................................................................... 38 
24 
APPENDICES ..................................................................................................................................................... 39 
 
 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 5 of 39 
1 Document History 
 
 
Protocol Version 
Number 
Date 
Description of Changes 
Change Author 
Rev 0 
22-Nov-
2019 
Creation of Study Document 
Nadja Schaetti 
Rev 1 
02-Dec-
2020 
Protocol template change from 
external to internally managed study. 
Update of deliverables from raw 
data to report 
Nadja Schaetti 
Rev 1.1 
02-Jul-
2021 
Updated to new Global CIP 
template, ISO reference updated to 
new Standard (ISO 14155:2020), 
MDCG reference added 
Brian Brissoni 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 6 of 39 
2 Contact Information/List of Investigators 
Title 
Post-market Clinical Follow-up Study to Provide Safety, 
Performance and Clinical Benefits Data of the Zimmer® 
Reconstruction System (Implant and Instrumentation) – A 
Retrospective Consecutive Series Study 
Single Identification 
Number (Clinical 
Investigational only as 
per Art. 70 of EU MDR) 
N/A 
Protocol Number 
MDRG-2017-89MS-99T 
Study Sponsor Contact 
Information 
Zimmer GmbH 
Zählerweg 4 
CH-6300 Zug 
Switzerland 
+41 (0)58 854 80 00 
Authorized 
Representative Contact 
Information, if applicable 
(Clinical Investigation 
only as per Annex XV of 
EU MDR) 
N/A 
Monitoring Contact 
Information 
Zimmer GmbH 
Zählerweg 4 
CH-6300 Zug 
Switzerland 
+41 (0)58 854 80 00 
Name(s) and 
Address(es) of Principal 
Investigators(s) and 
Coordinating 
Investigator(s), as 
appointed (Clinical 
Investigation only as per 
Annex XV of EU MDR) 
A complete listing and details including name, address, contact 
details and professional position of the Principal and Coordinating 
Investigators, as appointed, will be maintained the Sponsor’s Trial 
Master File. 
Investigational Site 
Information (Clinical 
The study will include 1 site.  Details regarding the site involved will 
be maintained in the Sponsor’s Trial Master File. 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 7 of 39 
Investigation as per 
Annex XV of EU MDR) 
External Organizations, if 
applicable 
N/A  
 
 
 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 8 of 39 
3 Abbreviations 
The following abbreviations are used throughout this study protocol:    
ADE 
Adverse Device Effect 
AE 
Adverse Event 
Case ID 
Case Identification Number 
CE 
Conformité Européene (European Conformity) 
CI 
Confidence Interval 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
DD 
Device Deficiency 
DoH 
Declaration of Helsinki 
EC 
Ethics Committee 
EMEA 
Europe, Middle East and Africa 
FUP 
Follow-up 
GDPR 
General Data Protection Regulation 
ICF 
Informed Consent Form 
ID 
Identification 
IFU 
Indications for Use 
ISO 
International Standards Organization 
MDCG 
Medical Device Coordination Group 
MDR 
Medical Device Regulation 
MEDDEV 
Medical Device Directive 
OP 
Operative 
PI 
Principal Investigator 
PMCF 
Post-Market Clinical Follow-Up 
PMSP 
Post Market Surveillance Plan 
Post-OP 
Post-operative 
PROM 
Patient-Reported Outcome Measures 
SADE 
Serious Adverse Device Effect  

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 9 of 39 
SAE 
Serious Adverse Event 
SS 
Study Subject 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 
 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 10 of 39 
4 Study Synopsis 
Complete Protocol Title 
Post-market Clinical Follow-up Study to Provide 
Safety, Performance and Clinical Benefits Data of the 
Zimmer® Reconstruction System (Implant and 
Instrumentation) – A Retrospective Consecutive Series 
Study 
Protocol Number 
MDRG2017-89MS-99T 
Short Protocol Title 
Zimmer Reconstruction System 
Sponsor 
Zimmer GmbH, Zug, Switzerland 
Manufacturer 
Zimmer Inc.  
Study Device(s) 
Zimmer Reconstruction System and respective 
instrumentation 
 
 
 
Straight Reconstruction Plate       
             
                         
Curved Reconstruction Plate 
 
Symphyseal B ridge plate 
 
 
Cortical screw 
Technical Documentation 
Reference Number 
401, 402a, 402s, 425b, 850 
Study Objectives/Endpoints 
The objective of this retrospective post-market clinical 
follow-up (PMCF) study is to collect data confirming 
safety, performance and clinical benefits of the Zimmer 
Reconstruction System (implants and instrumentation) 
when used for temporary internal fixation and 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 11 of 39 
stabilization of fractures during the normal healing 
process. 
 
The primary objective is the assessment of performance 
by analyzing fracture healing. 
 
The secondary objectives are the assessment of safety 
by recording and analyzing the incidence and frequency 
of complications and adverse events. Relation of the 
events to implant, instrumentation and/or procedure 
should be specified. Subjects’ outcomes will also be 
assessed. 
Indications/Target Population 
Consecutive series of cases implanted with the Zimmer 
Reconstruction System according to the indications for 
use. Inclusion/exclusion criteria are in accordance with 
the indications and contraindications in the Instruction 
For Use (IFU). 
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
Patients having received the Zimmer Reconstruction 
System for temporary internal fixation and stabilization 
of fractures during the normal healing process. 
 
Exclusion Criteria: 
 
Off-label use 
 
Patients under the age of 18 
 
Severely comminuted fractures in which bone 
fragments are too small or numerous to 
adequately fix or maintain a reduced position. 
 
Infection. 
 
Metal sensitivity or intolerance. 
 
Severe osteopenia and/or osteoporosis, or in 
the presence of marked or rapid bone 
absorption, metabolic bone disease, cancer, or 
any other tumor-like condition of the bone which 
may compromise fixation. 
 
Sternal or spinal fractures. 
 
Anatomical location in which the device would 
interfere with nerves, blood vessels, or other 
vital structures. 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 12 of 39 
 
Patients with inadequate soft tissue coverage at 
the implant site. 
Study Design 
Single-Center, Retrospective, Non-controlled, Non-
randomized, Consecutive series 
Clinical Phase 
Post-market 
Sample Size  
The goal is to collect data on a total of 83 consecutive 
cases operated with the the Straight Reconstruction 
Plate, Curved Reconstruction Plate and/or Symphyseal 
Bridge Plate, aiming for an equal number of each.  
Length of Study 
12 months overall: 
 
Ethics Committee approval  
 
Identify and enroll subjects into the study 
 
Collection of baseline and follow-up (FUP) 
information available in medical notes from the 
pre-operative condition to the immediate post-op 
and last consultation visit 
 
Conduct data collection and analysis 
 
Write the final report 
Materials and Methods 
Retrospective data will be collected from medical charts 
including baseline information from the preoperative, 
operative, immediate post-operative interval and last 
consultation visit. Zimmer Biomet will receive only an 
anonymized report. 
Data Collection 
Paper/Electronic 
Statistical Reporting 
Statistical Analysis will be conducted by the Azienda 
Ospedaliero Universitaria Senese, Siena, Italy.  
Scores/Performance 
Assessments 
Harris Hip Score (HHS), Fracture Healing, Adverse 
Events 
Standards 
The PMCF is compliant with the below: 
 
ISO 14155: 2020 - Clinical investigation of medical 
devices for human subjects - Good clinical practice 
[1]. 
 
The Declaration of Helsinki (DoH) - Ethical 
principles for medical research involving human 
subjects [2]. 
 
European Regulation (EU) 2017/745 [3]. 
 
MDCG 2020-10/1 Safety reporting in clinical 
investigations for medical devices under the 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 13 of 39 
Regulation (EU) 2017/74 [4] 
Study Funding 
Funding for this clinical study is made available by 
Zimmer Biomet to support clinical data collection, EC 
review fees and other expenses associated with the 
conduct and execution of this study protocol as outlined 
in the fully executed Clinical Trial Agreement. 
 
 
 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 14 of 39 
5 Data Collection Overview 
The following information and data will be collected on all cases: 
Evaluation 
Baseline 
Last 
Consultation 
Visit (min. 1 year 
post-op) 
Prior to 
Surgery 
Surgical/Operative Immediate Post-
Operative 
Inclusion/Exclusion 
Criteria 
 
PI 
 
 
 
Demographic Evaluation 
PI 
 
 
 
Physical Exam 
 
 
PI 
 
Operative Information/ 
Surgical Device 
Information 
 
PI 
 
 
Immediate Post-Operative 
Evaluation 
 
 
PI 
 
Harris Hip Score [5]. 
 
 
 
PI 
Fracture Healing 
(including x-rays and/or 
clinically) 
 
 
 
PI 
Protocol Deviation 
 
If  required 
 
Complications/Adverse 
Events (AE relation or 
not to device, 
instrumentation and/or 
procedure) 
 
PI:  completed by Principal Investigator or qualified designee 
 
 
 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 15 of 39 
6 Introduction and Purpose 
Falls and motor vehicle accidents, the two most common mechanisms of traumatic injury [4, 
5], sometimes result in fractures or other disruptions of the pelvic ring. Fractures following 
high-energy trauma are often associated with extensive soft tissue injuries. The state of the 
surrounding soft tissues and the local blood supply to the bone are the most important factors 
determining the tendency of the fracture to heal [6-12]. In high-energy pelvic trauma fractures, 
temporary fixation with plates is indicated to stabilize the pelvic ring in order to control 
hemorrhage, creates high stability and reduces motion in the joint or at the fracture site. 
The Zimmer Reconstruction System is a CE marked and FDA cleared implant system that 
has been in clinical use since 1995. The purpose of this retrospective PMCF study is to 
confirm safety, performance and clinical benefits of the Zimmer Reconstruction System when 
used for temporary internal fixation and stabilization of fractures during the normal healing 
process. 
7 Study Device Information 
7.1 Study Device 
The Zimmer Reconstruction System is designed to provide temporary fixation of fractures primarily in 
the pelvic region. The implant system is comprised of straight, curved, and symphyseal bridge 
reconstruction plates and screws used to fix the plates to the fractured bones. The plates, screws and 
spherical washers that are manufactured from 316L stainless steel and are provided in a range of 
sizes and lengths to accommodate patient size and skeletal morphology. Representative illustrations 
of each implant type, screws and ancillary components appear in Figures 1 (1a through 1e). 
 
 
 
Figure 1:  Zimmer Reconstruction System implants, screws and ancillary components 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
CONFIDENTIAL 
GBLF12202 Rev 3 
Ref: GBLW12202 Clinical Investigation Protocol/Amendment Development & Approval for Clinical Trials  
Page 16 of 39 
 
The plates are malleable so they can be precisely contoured to the appropriate shape using plate 
bending instrumentation as shown in Figure. 2. 
 
 
Figure 2: Bending Pliers Holding a Curved Reconstruction Plate 
 
The plates are available in non-sterile and sterile versions and can accommodate bone screws.  
 
7.2  Device Scope 
For simplicity purposes, only the plates and washers are listed in the scope below, however the study 
aims to collect data on all implants and instruments (incl. ancillary components) of the Zimmer 
Reconstruction System. 
 
Part Number 
Sterile 
Part Number 
Unsterile 
Item description 
00-1179-002-02 
47-1179-002-02 
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BRIDGE PLATE 4 HOLES   LARGE 
00-1179-002-04 
47-1179-002-04 
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BRIDGE PLATE 4 HOLES   SMALL 
00-1179-005-03 
47-1179-005-03 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 3 HOLES 
00-1179-005-04 
47-1179-005-04 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 4 HOLES 
00-1179-005-05 
47-1179-005-05 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 5 HOLES 
00-1179-005-06 
47-1179-005-06 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 6 HOLES 
00-1179-005-07 
47-1179-005-07 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 7 HOLES 
00-1179-005-08 
47-1179-005-08 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 8 HOLES 
00-1179-005-09 
47-1179-005-09 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 9 HOLES 
00-1179-005-10 
47-1179-005-10 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 10 
HOLES 
00-1179-005-11 
47-1179-005-11 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT, 11 
HOLES 
00-1179-005-12 
47-1179-005-12 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 12 
HOLES 
00-1179-005-13 
47-1179-005-13 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT, 13 
HOLES 

 
 
 
Zimmer Reconstruction System  
MDRG2017-89MS-99T 
Protocol Revision 1.1 & 02 Jul 2021 
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GBLF12202 Rev 3 
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00-1179-005-14 
47-1179-005-14 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 14 
HOLES 
00-1179-005-15 
47-1179-005-15 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT, 15 
HOLES 
00-1179-005-16 
47-1179-005-16 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 16 
HOLES 
00-1179-005-18 
47-1179-005-18 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT 18 
HOLES 
00-1179-005-20 
47-1179-005-20 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - STRAIGHT, 20 
HOLES 
00-1179-005-22 
47-1179-005-22 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE- STRAIGHT, 22 
HOLES 
00-1179-006-06 
47-1179-006-06 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - CURVED 6 HOLES 
00-1179-006-08 
47-1179-006-08 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - CURVED 8 HOLES 
00-1179-006-10 
47-1179-006-10 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - CURVED 10 HOLES 
00-1179-006-12 
47-1179-006-12 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - CURVED 12 HOLES 
00-1179-006-14 
47-1179-006-14 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - CURVED 14 HOLES 
00-1179-006-16 
47-1179-006-16 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - CURVED 16 HOLES 
00-1179-006-18 
47-1179-006-18 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - CURVED 18 HOLES 
00-1179-006-20 
47-1179-006-20 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - CURVED, 20 HOLES 
00-1179-006-22 
47-1179-006-22 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - CURVED, 22 HOLES 
00-1179-006-24 
47-1179-006-24 
ZIMMER RECONSTRUCTION SYSTEM 3.5 MM RECON BONE PLATE - CURVED, 24 HOLES 
00-1179-007-02 
47-1179-007-02 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 2 HOLES 
00-1179-007-03 
47-1179-007-03 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 3 HOLES 
00-1179-007-04 
47-1179-007-04 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 4 HOLES 
00-1179-007-05 
47-1179-007-05 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 5 HOLES 
00-1179-007-06 
47-1179-007-06 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 6 HOLES 
00-1179-007-07 
47-1179-007-07 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 7 HOLES 
00-1179-007-08 
47-1179-007-08 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 8 HOLES 
00-1179-007-09 
47-1179-007-09 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 9 HOLES 
00-1179-007-10 
47-1179-007-10 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 10 HOLES 
00-1179-007-11 
47-1179-007-11 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 11 HOLES 
00-1179-007-12 
47-1179-007-12 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 12 HOLES 
00-1179-007-13 
47-1179-007-13 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 13 HOLES 
00-1179-007-14 
47-1179-007-14 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 14 HOLES 
00-1179-007-15 
47-1179-007-15 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 15 HOLES 
00-1179-007-16 
47-1179-007-16 
ZIMMER RECONSTRUCTION SYSTEM 4.5 MM STRAIGHT RECON PLATE 16 HOLES 
00-1179-013-06 
47-1179-013-06 
ZIMMER RECONSTRUCTION SYSTEM 2.7 MM STRAIGHT RECON PLATE 6 HOLES 
00-1179-013-08 
47-1179-013-08 
ZIMMER RECONSTRUCTION SYSTEM 2.7 MM STRAIGHT RECON PLATE 8 HOLES 
00-1179-013-10 
47-1179-013-10 
ZIMMER RECONSTRUCTION SYSTEM 2.7 MM STRAIGHT RECON PLATE 10 HOLES 
00-1179-013-12 
47-1179-013-12 
ZIMMER RECONSTRUCTION SYSTEM 2.7 MM STRAIGHT RECON PLATE 12 HOLES 
00-1179-013-14 
47-1179-013-14 
ZIMMER RECONSTRUCTION SYSTEM 2.7 MM STRAIGHT RECON PLATE 14 HOLES 
00-1179-013-16 
47-1179-013-16 
ZIMMER RECONSTRUCTION SYSTEM 2.7 MM STRAIGHT RECON PLATE 16 HOLES 
00-1179-013-18 
47-1179-013-18 
ZIMMER RECONSTRUCTION SYSTEM 2.7 MM STRAIGHT RECON PLATE, 18 HOLES 
00-1179-013-20 
47-1179-013-20 
ZIMMER RECONSTRUCTION SYSTEM 2.7 MM STRAIGHT RECON PLATE, 20 HOLES 

 
 
 
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00-1179-013-22 
47-1179-013-22 
ZIMMER RECONSTRUCTION SYSTEM 2.7 MM STRAIGHT RECON PLATE, 22 HOLES 
00-1179-013-24 
47-1179-013-24 
ZIMMER RECONSTRUCTION SYSTEM 2.7 MM STRAIGHT RECON PLATE, 24 HOLES 
 
Table 1. Device Scope of the Zimmer Reconstruction System Implants 
 
7.3 Instrumentation 
The instruments are made of stainless steel. Some instruments, such as screwdrivers, have plastic 
handles. Implant and instrument cases store the plates and associated instrumentation and house 
them during sterilization. 
 
Figure 3: Pelvic Reconstruction Instrument Set 
 
Figure 4: Pelvic Reconstruction Clamp Set 
 
7.4 Ancillary devices 
The Spherical washers are used to increase screw head size and fit flush, for fracture fixation 
optimizing the compression and minimize intrusion of the screw head through the bone during screw 
insertion (see table 2). 
 
Part number 
Item description 
00-1179-012-00 
ZIMMER RECONSTRUCTION SYSTEM SPHERICAL WASHER FOR USE WITH 3.5 MM SCREW 

 
 
 
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00-1179-015-00 
ZIMMER RECONSTRUCTION SYSTEM SPHERICAL WASHER 2.7 MM I.D. 
 
Table 2. Zimmer Reconstruction System ancillary components 
 
7.5 Compatibility 
 
To determine whether devices have been authorized for use in a proposed combination with Zimmer 
and/or Biomet products, please contact your sales representative or visit the Zimmer Electronic 
Labeling Service (eLabeling) website: https://labeling.zimmerbiomet.com/. 
 
 
7.6 Accountability of devices 
Device accountability is not required for this study. The devices used in the study are commercially 
available via CE 515162.  
  
8 Study Population 
The study population will be comprised of a consecutive series of cases implanted with the 
Zimmer Reconstruction System according to Zimmer Biomet’s IFU and meeting the inclusion 
criteria and none of the exclusion criteria of this study. Inclusion/exclusion criteria are based 
on the indications and contraindications in the IFU. See below inclusion and exclusion criteria 
to be considered to determine patient`s eligibility. 
8.1 Inclusion Criteria 
Patients having received the Zimmer Reconstruction System for temporary internal fixation and 
stabilization of fractures during the normal healing process. 
 
8.2 Exclusion Criteria 
The exclusion criteria are: 
• 
Off-label use 
• 
Patients under the age of 18 
• 
Severely comminuted fractures in which bone fragments are too small or numerous to 
 
adequately fix or maintain a reduced position 
• 
Infection 
• 
Metal sensitivity or intolerance 
• 
Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone 
 
absorption, metabolic bone disease, cancer, or any other tumor-like condition of the 

 
 
 
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bone which may compromise fixation 
• 
Sternal or spinal fractures 
• 
Anatomical location in which the device would interfere with nerves, blood vessels, or 
 
other vital structures 
• 
Patients with inadequate soft tissue coverage at the implant site. 
 
9 Study Objectives 
This is a PMCF study to fulfil the post-market surveillance obligations according to Medical 
Device Directive, MEDDEV 2.12-2 and the Medical Devices Regulation (MDR 2017/745). The 
objective of this retrospective PMCF study is to collect data confirming safety, performance 
and clinical benefits of the Zimmer Reconstruction System (implant and instrumentation) when 
used for temporary internal fixation and stabilization of fractures during the normal healing 
process.  
 
 Performance will be evaluated by assessing bone union radiographically and/or clinically 
 
 Safety will be evaluated by monitoring the frequency and incidence of adverse events 
(AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device 
effects (SADE), unanticipated serious adverse device effects (USADE) and device 
deficiencies (DD). Relation of the events to implant, instrumentation and/or procedure 
should be specified. 
 
 Clinical benefits will be determined by the Harris Hip Score recorded at the longest follow-
up after surgery (at least 1 year post-operative). 
 
 
10 Study Design and Endpoints 
10.1 Disease/Condition Being Treated 
In this study the Zimmer Reconstruction system is used to stabilize fractures through temporary 
internal fixation during the normal healing process. 
10.2 Number of Sites and Regions 
This is a monocentric study performed at the Hospital Azienda Ospedaliero Universitaria Senese 
in Siena, Italy. 
10.3 Number of Cases and Maximum Enrollment per Investigation Site 
The goal is to collect data on a total of 83 consecutive cases operated with the Straight Reconstruction 
Plates, Curved Reconstruction Plates and/or Symphyseal Bridge Plates defined in the device scope 

 
 
 
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section of this protocol, aiming for an equal number of each. 
10.4 Participating Investigators and Roles (if applicable) 
A list of the participating Investigators and their roles can be found in the Appendix B of this document 
and the Sponsor’s Trial Master File. 
10.5 Study Design  
This is a monocentric, retrospective and consecutive series post-market clinical study. Consecutive 
series of cases implanted with the Zimmer Reconstruction System between 2010 and 2018 at the 
Hospital Azienda Ospedaliero Universitaria Senese in Siena, Italy will be identified and included in the 
study. The consecutive cases will be enrolled in the reverse chronological order that they were 
operated. This means enrollment will start with patients operated in 2018 and consecutively going 
backwards towards 2010 until the necessary number of cases has been reached. 
10.6 EC Approval 
Ethics Committee (EC) approval will be obtained prior to conducting this study. No informed consent, 
nor data protection regulation notice is needed as Zimmer Biomet will only receive a completely 
anonymized report and will not have access to any pseudonymized patient data.  
10.7 Type and Timing of Observations 
This study is designed to be retrospective. To avoid bias, consecutive series of cases will be identified 
and included in the study.  The study duration is expected to be 12 months overall, which corresponds 
to time dedicated to the retrospective data collection from hospital charts from the pre-operative 
condition to the last consultation visit (at least 1-year post-operative), to conduct the analysis and to 
draft the final report. 
10.8 Primary and Secondary Endpoint 
The aim of this retrospective PMCF study is to collect data confirming safety, performance and clinical 
benefits of of the Zimmer Reconstruction System and its instrumentation when used for temporary 
internal fixation and stabilization of fractures during the normal healing process. 
10.8.1 Primary Endpoint 
The primary endpoint is the radiographical and/or clinical assessment of fracture healing 
(performance). 
 
10.8.2 Secondary Endpoint 
The secondary endpoint is the assessment of safety by recording and analyzing the 
incidence and frequency of complications and adverse events. Relation of the events to 
implant, instrumentation and/or procedure should be specified.  Subjects’ outcomes will 
also be assessed. 
10.9 Study Hypothesis  

 
 
 
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10.10 Since this study is an observational study no hypothesis is used in the study. 
Financing of the Study 
Funding for this clinical study is made available by Zimmer Biomet to support clinical data collection, 
EC review fees and other expenses associated with the conduct and execution of this study protocol 
as outlined in the fully executed Clinical Trial Agreement (CTA). 
10.11 Definition of Completion of the Study 
This study will be completed once an anonymized final report will be provided to and accepted by 
Zimmer Biomet on a total number of 83 cases treated with the Zimmer Reconstruction System. 
11 Study Procedures 
11.1 Study Participation 
Each consecutive case implanted with the Zimmer Reconstruction System for temporary internal 
fixation and stabilization of fractures during the normal healing process between 2010 and 2018 at the 
Hospital Azienda Ospedaliero Universitaria Senese in Siena, Italy will be identified and included in the 
study until the required sample size of 83 cases is reached. 
11.2 Informed Consent 
All Subject related data will be kept anonymized. Patient confidentiality will be protected at all times 
and patients’ identifiers will not be included in summaries of the data. The study sponsor will only 
receive an anonymized final report, therefore no patient consent is needed. 
11.3 Information on Data Handling and Processing (GDPR notice) 
Due to the retrospective design of this study and the delivery of anonymized data in a final report, no 
GDPR notice and consent is needed.  
11.4 Study Logs 
11.4.1 Subject Screening Log 
All patients who received the Zimmer Reconstruction System between 2010 and 2018 must 
be entered into the Subject Screening Log sequentially regardless of their eligibility.  
11.4.2 Subject Identification Log 
The site shall maintain a log of all subjects included in the clinical investigation, assigning 
an identification code linked to their names, alternative subject identification or contact 
information. All patients who meet the inclusion criteria and none of the exclusion criteria 
must be entered on the log sequentially. If a subject receives multiple implants, a dataset 
will be recorded per fractured site. Each case, i.e. fractured site, will have a different 
identification code. A Subject Identification Log must be maintained throughout the study 
and is included in the Investigator Binder. This list is kept in a safe place in the hospital.  
11.5 Determination of Eligibility and Enrollment 

 
 
 
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Patient eligibility for enrollment will be determined based upon the inclusion/exclusion criteria. Patients 
must have received the Zimmer Reconstruction System between 2010 and 2018 at the Hospital 
Azienda Ospedaliero Universitaria Senese in Siena, Italy and meet the inclusion criteria and none of 
the exclusion criteria in order to be included in the study. 
11.6 Pre-operative Assessment 
For each case, baseline data will be collected and will include, but will not be limited to the following: 
o Inclusion/Exclusion Criteria 
o Demographics: 
 
Age at operation 
 
Gender 
 
Weight 
 
Height 
 
Concomitant diseases 
 
Confounders for bone union 
o Diagnosis: 
 
Fracture cause (e.g. fall from height, motor vehicle accident) 
 
Fracture classification (Tile’s classification for pelvic ring fractures, AO or Judet 
classification for acetabulum fractures) (7; 8; 9; 10) 
 
Open or closed fracture 
 
Existence of additional fractures (i.e. polytrauma) 
o Study deviation, if any 
11.7 Surgical Techniques 
The surgical technique for the Zimmer Reconstruction System is provided in the Regulatory Binder. 
The use of the study device was according to the IFU and the hospital’s standard reconstruction 
procedures. 
11.8 Surgical/Immediate Post-Operative Assessment 
Operative and immediate post-operative data will include, but not be limited to the following: 
o Op-Date 
o Op-Duration (skin-to-skin, min) 
o Product/Instrument specifications (e.g. catalogue number, plate type and size, screws used) 
o Physical exam: ROM, motility, neurological basic exam 
o Radiographic Evaluation  
o Length of hospital stay 
o Intra-op and immediate post-op complications, adverse events. (Relation of the events to 
implant, instrumentation and/or procedure should be specified) 
o Study deviation, if any 
11.9 Follow-up Procedures  
Follow-up evaluation was conducted at a minimum of 1 year after surgery. Data collection will include 
but is not limited to the following: 
o FUP date 

 
 
 
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o Fracture healing (union/non-union) evaluated by x-ray and/or clinically 
o Pain and functional performance as reported by the Harris Hip Score (3) 
o Adverse events and complications and date of its occurrence (relation to implant, 
instrumentation and/or procedure should be specified) 
o Revisions/Implant removal date and reason (relation to implant, instrumentation and/or 
procedure should be specified 
o Study deviation, if any 
11.10 Minimization of Loss to Follow-up 
Due to the retrospective design of the study, no follow up visits are planned. Therefore no loss to 
follow-up is applicable. 
11.11 Radiographic Definitions and Methods 
 
Standard radiographs of the operated bone are captured during the last consultation visit, if 
available.  
 
Radiographic parameters include but are not limited to documentation of bone union and any 
significant radiographic findings. 
 
All radiographic evaluations performed according to the protocol will be reviewed by the 
investigator for significant radiographic findings. If a radiographic significant event is identified 
by the investigator he/she must document the event and report the radiographic findings as 
needed. 
11.12 Recommended Revision Procedure 
No revision arm is planned in this study. 
11.13 Explant Procedure 
In the event a study subject required a revision surgery all explanted components should have been 
returned to Zimmer Biomet for analysis. Upon removal, the investigator must record his/her findings 
i.e. damage on the device 
In case of an explant procedure each component should be wrapped separately in a compress (or 
similar material) immersed in 10% formalin and place each component in a separate labeled container 
to prevent damage during shipping. The implant container(s) should be labelled to identify the catalog 
number, investigator name, case ID, date of removal, and include a statement indicating the implant 
is from a clinical study.  
Each wrapped implant specimen and any tissue container should be placed into a Bio-hazardous 
Material bag.  Bio-hazard bag should be placed inside a second sealed container. 
All explanted devices should be returned to: 
Zimmer Biomet 
Attention: Product Services Department 
1777 W. Center Street 

 
 
 
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Warsaw, IN  46580 
USA 
 
 
12 Reporting 
12.1 Activities Required Prior to Initiation of the Study 
12.1.1 Clinical Trial Agreement (CTA) and Financial Arrangements 
A fully executed (signed by all required parties) CTA must be on file with the Sponsor prior 
to any investigator participating in this study. This agreement must explain the financial 
arrangement with the investigative site. 
12.1.2 Ethics Committee Protocol Approval 
This study protocol must be submitted to and approved by the Investigator’s EC. A copy 
of the EC approval letter must be submitted to the Sponsor. The letter should identify the 
following: 
 
Protocol name and/or number. 
 
Date of EC meeting (if available). 
 
Date of approval. 
 
Date of expiration. 
 
Signature of EC. 
12.1.3 Clinicaltrials.gov Registration 
The Sponsor will be responsible for registering this study on www.ClinicalTrials.gov if 
required by local and national regulations. 
12.2 Clinical Data Collection/Submission 
12.2.1 Summary of Data Collection 
Study data will be summarized in an anonymized final report. A final report template will 
be provided by the Sponsor. Study data will be collected from patients charts and 
transferred into a study-specific Excel database. The database will not be shared with the 
Sponsor. If a subject receives multiple implants, a dataset will be recorded per fractured 
site.  
The following completion guidelines should be followed:  
 
Complete carefully and accurately. 
 
Be sure that data on the source documents match that which is entered in the 
database.  
 
Ensure that all fields are completed. The investigator must retain the subject data 
sources in accordance with local law and regulations.  
 
The investigator should take measures to prevent accidental or early destruction of 
the study related materials. 

 
 
 
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 
Ensure that data in the final report is aligned with the source data. 
The following information and data will be collected on all cases and summarized in the 
final report: 
 
Preoperative Information: Inclusion/Exclusion criteria, demographic data, and 
diagnosis. 
 
Operative and Immediate Postoperative Information: Date of surgery, 
duration of surgery, operated side, surgical device information (devices, 
ancillary devices, instrumentation), length of hospital stay, complications and 
adverse events. 
 
Last Consultation Visit (at least 1 year post-op): Date of visit, radiographic 
assessment of fracture healing (if available), clinical assessment of fracture 
healing, complications and adverse events and Harris Hip Score. 
 
Adverse Events: Complications, reoperations, revisions 
 
Protocol Deviation, if applicable 
12.2.2 Data Submission 
The final report will be sent to Zimmer Biomet. The completed database will remain at the 
hospital 
and 
will 
not 
be 
shared 
with 
Zimmer 
Biomet. 
Copies of the original x-rays taken at the site during the indicated evaluations should be 
made available to the Sponsor upon request. The original paper source documents, if any, 
must be kept in a secure location during the course of the study and maintained in 
accordance with regional and/or national laws/regulations, and EC requirements.  
Each party will notify the other party without undue delay upon becoming aware of any 
Personal Data Breach affecting Patient and /or User Personal Data. The parties will 
cooperate fully with each other and use commercially reasonable endeavors to assist each 
other in relation to any reporting or notification obligations in the event of a Personal Data 
Breach affecting Patient and/or User Personal Data. Further details for handling potential 
data breach can be found in the respective section in the CTA. 
12.2.3 Quality Assurance of Data 
The Investigator should ensure the accuracy, completeness, legibility, and timeliness of 
the data reported to the Sponsor in the final report. Data summarized in the final report 
should be consistent with the source documents or the discrepancies should be explained. 
12.2.4 Patient Privacy and Identification 
All patient related data will be kept anonymized and Zimmer Biomet will only receive an 
anonymized final report..  
12.2.5 Data Management 
The Investigator and his team is responsible for the data management since the Sponsor only receives 
an anonymized final report.  
12.3 Reporting Requirements 
12.3.1 Investigator Reporting Responsibilities  

 
 
 
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The Investigator should ensure the accuracy, completeness, legibility, and timeliness of 
data reported to the Sponsor in accordance with this protocol. The Investigator or 
Designee will provide periodic reports to their EC as required to maintain EC approval 
throughout the study and will provide any required final reporting to the EC upon study 
completion/termination. A copy of all EC (re-)approval letters must be submitted to the 
Sponsor. If the EC terminates or suspends its approval of the study, the Investigator or 
Designee will suspend study-related activities and will promptly notify the Sponsor. The 
Investigator should also promptly provide written reports to the Sponsor and the EC 
regarding any changes significantly affecting the conduct of the study, and/or increasing 
risk to the subjects.  
12.3.2 Retention of Records 
Study records must be retained by the Investigator or Designee for a minimum of 15 years 
from the Investigator’s study termination date, or per applicable regulatory and/or EC 
requirements (whichever time period is greater and allowed by local regulation).  Measures 
shall be taken to prevent accidental or premature destruction.  
Study records are defined as all information in original records, certified copies of original 
records of clinical findings, observations or other activities in a clinical study, including 
source data initially recorded in an electronic format, necessary for the reconstruction and 
evaluation of the clinical study.  This may include but is not limited to: hospital records, 
clinic records, laboratory notes, device accountability records, photographs, radiographs, 
subject casebooks, regulatory records, and all other study-related documents 
  
12.4 Management of Intercurrent Events 
12.4.1 Failure to Obtain Informed Consent and/or GDPR notice  
Due to the retrospective design of this study, Informed Consent and GDPR consent s not 
required. 
12.4.2 Revision 
In the event that removal of one or more of the study related components was necessary, 
the Investigator has determined the best treatment and/or revision method for the subject. 
All revision surgeries should be reported as Adverse Events in the  
final report. 
12.4.3 Investigator Withdrawal 
Due to the retrospective design of this study, investigator withdrawal is not applicable for 
this study. 
12.4.4 Subject Withdrawal 
Due to the retrospective design of this study, subject withdrawal is not applicable for this 
study. 
12.4.5 Lost to Follow-up 
Due to the retrospective design of this study, lost to follow-up are not applicable. 
12.4.6 Protocol Deviations 

 
 
 
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The Investigator should not deviate from the agreed upon protocol unless it is to eliminate 
hazard to the patient. However, any deviation from the protocol has to be documented 
along with an explanation for the deviation and reported to the Sponsor. Each significant 
deviation will be reported to the Ethics Committee, if applicable, within the appropriate 
deadlines stipulated by the appropriate regulatory authorities. Significant deviations are 
defined as those impacting or potentially impacting patient safety. The Sponsor shall take 
appropriate corrective and preventative actions to protect the safety of subjects, users, 
and other persons. Investigator disqualification criteria leading to exclusion from the clinical 
study include fraud, misconduct and serial non-compliance. 
12.4.7 Study Termination 
The study terminates after Zimmer Biomet has received and approved the final report. If 
the Sponsor decides to terminate the study early, the Sponsor will inform the Investigator 
of the reason for early study termination.  It is the responsibility of the Investigator to inform 
their EC as applicable according to local and national laws/regulations. 
12.4.8 Adverse Events 
See Safety Management – Medical Events/Adverse Events Section of this protocol for 
additional information regarding adverse event classifications.   
Reporting and Documentation of Adverse Events and Adverse Device Effects  
Adverse Events and Adverse Device Effects have to be documented ideally including 
information on the type of event, date of onset, treatment and resolution, as well as 
assessment of both the seriousness and the relationship to the study device, 
instrumentation and/or procedure. Further, the outcome of complications has to be 
documented and summarized in the final report. In case of early termination of the study, 
further follow-up of the patient shall proceed according to the hospital’s standard 
procedure. 
Reporting and Documentation of Serious Adverse Events, Serious Adverse Device 
Effects, and Device Deficiencies 
Serious Adverse Events and Serious Adverse Device Effects have to be reported to 
the Sponsor as soon as possible. The incidence has to be documented over the whole 
time of the investigation ideally including information on the type of event, date of onset, 
treatment and resolution, as well as assessment of both the seriousness and the 
relationship to the study device, instrumentation and/or procedure based on the evaluation 
of the investigator. The outcome of such complications has to be documented and 
summarized in the final report. In case of early termination of the study, further follow-up 
of the study subject shall proceed according to the hospital’s standard procedure. 
Device Deficiencies that did not lead to an adverse event but could have led to a medical 
occurrence if suitable actions had not been taken, if intervention had not been made or if 
circumstances had been less fortunate shall be reported to the Sponsor as soon as 
possible, as well. 
The Investigator is responsible for reporting all SAEs, SADEs, USADEs and Device 
Deficiencies that could have led to a SADE to the Ethics Committee if required by national 
regulations or by the EC. 

 
 
 
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13 Safety Management – Medical Events/Adverse Events  
Adverse events are required to be summarized in the final report.. The Investigator or Designee will 
also promptly provide the Sponsor with any additional requested information required for the Sponsor 
to comply with regulatory requirements. If applicable per their reporting requirements, the Investigator 
or Designee will also report applicable adverse event(s) to their EC. 
The following definitions are from ISO 14155:2020 [1]. 
13.1 Classification of the Event 
13.1.1 Adverse Event (AE) 
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device and whether anticipated or unanticipated. 
Note 1:  This definition includes events related to the investigational medical device or the 
comparator. 
Note 2:  This definition includes events related to the procedures involved. 
Note 3:  For users or other persons, this definition is restricted to events related to the use 
of investigational medical devices or comparators.  
13.1.2 Serious Adverse Event (SAE) 
A Serious Adverse Event is an adverse event that led to any of the following: 
a. death, 
b. serious deterioration in the health of the subject, users or other persons as defined 
by one or more of the following: 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function including 
chronic diseases, or 
3. in-patient or prolonged hospitalization, or 
4. medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
c. fetal distress, fetal death, a congenital abnormality or birth defect including physical 
or mental impairment. 
Note:  Planned hospitalization for a pre-existing condition, or a procedure required by the 
protocol, without serious deterioration in health, is not considered a serious adverse event. 
 
13.1.3 Serious Health Threat 
Signal from any adverse event or device deficiency that indicates an imminent risk of death 
or a serious deterioration in the health of subjects, users or other persons, and that requires 
prompt remedial action for other subjects, users or other persons. 

 
 
 
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Note 1:  This would include events that are of significant and unexpected nature such that 
they become alarming as a potential serious health hazard or possibly of multiple deaths 
occurring at short intervals. 
13.1.4 Adverse Device Effect (ADE) 
An Adverse Device Effect is an adverse event related to the use of an investigational 
medical device. 
Note 1:  This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment implantation, installation, or operation, or any malfunction 
of the medical device. 
Note 2:  This definition includes any event resulting from use error or from intentional 
misuse of the medical device. 
Note 3: This includes ‘comparator’ if the comparator is a medical device. 
13.1.5 Serious Adverse Device Effect (SADE) 
A Serious Adverse Device Effect is an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
13.1.6 Unanticipated Serious Adverse Device Effect (USADE) 
An unanticipated adverse device effect is a serious adverse device effect which by its 
nature, incidence, severity or outcome has not been identified in the current risk 
assessment. 
Note 1:  Anticipated serious adverse device effect (ASADE) is an effect which by nature, 
incidence, severity or outcome has been identified in the risk assessment. 
13.1.7 Device Deficiency (DD) 
A Device Deficiency is defined as an inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, usability, safety or performance.  
Note 1:  Device Deficiencies include malfunctions, use errors, and inadequacy in the 
information supplied by the manufacturer including labelling.  
Note 2: This definition includes device deficiencies related to the investigational 
medical device or comparator. 
It is important to document in the study also all device deficiencies that could have led to 
a medical occurrence but did not lead to an adverse event. 
13.2 Causality Assessment (Relation to Device) 
The relationship between the use of the medical device (including the medical - surgical 
procedure) and the occurrence of each adverse event shall be assessed and categorized. During 
causality assessment activity, clinical judgement shall be used and the relevant documents, such 
as the Investigator’s Brochure, the Clinical Investigation Plan or the Risk Analysis Report shall 
be consulted, as all the foreseeable serious adverse events and the potential risks are listed and 
assessed 
there. 
The 
presence 
of 
confounding 
factors, 
such 
as 
concomitant 
medication/treatment, the natural history of the underlying disease, other concurrent illness or 
risk factors shall also be considered. 

 
 
 
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Each adverse event will be classified according to four different levels of causality: 
 Not Related 
 Possible (Uncertain) 
 Probable 
 Causal Relationship (Definitely related) 
The Sponsor and the investigators will use the following definitions to assess the relationship of 
the adverse event to the investigational device, the comparator or the investigation procedure. 
13.2.1 Not Related 
Relationship to the device, comparator or procedures can be excluded when the event has 
no temporal relationship with the use of the investigational device, or the procedures 
related to application of the investigational device. 
13.2.2 Possible (Uncertain)  
The relationship with the use of the investigational device or comparator, or the relationship 
with procedures, is weak but cannot be ruled out completely.  Alternative causes are also 
possible (e.g. an underlying or concurrent illness/ clinical condition or/and an effect of 
another device, drug or treatment).  Cases where relatedness cannot be assessed, or no 
information has been obtained should also be classified as possible. 
13.2.3 Probable  
The relationship with the use of the investigational device or comparator, or the relationship 
with procedures, seems relevant and/or the event cannot be reasonably explained by 
another cause. 
13.2.4 Causal Relationship (Definitely related)  
The serious adverse event is associated with the investigational device, comparator or 
with procedures beyond reasonable doubt. 
Note:  Complications caused by concomitant treatments not imposed by the clinical 
investigation plan are considered not related.  Similarly, several routine diagnostic or 
patient management procedures are applied to patients regardless of the clinical 
investigation plan.  If routine procedures are not imposed by the clinical investigation plan, 
complications caused by them are also considered not related. 
13.3 Review of Reported Events 
The Sponsor will review the investigator’s assessment of all reported events submitted to 
determine and document in writing their seriousness and relationship to the study device 
and related procedures required by this protocol. In case of disagreement, the sponsor will 
consult the investigator for clarification and correction if required. If the disagreement 
cannot be resolved, the Sponsor shall communicate both opinions to the Post Market 
Surveillance team for further investigation and required reporting if applicable.  
13.4 Intensity of Symptoms 
13.4.1 Mild 

 
 
 
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The subject is aware of the sign or symptom, but finds it easily tolerated. The event is of 
little concern to the subject and/or little clinical significance. The event is not expected to 
have any effect on the subject’s overall health or well-being. 
13.4.2 Moderate 
The subject has discomfort enough to cause interference with or a change in usual 
activities. The event is of some concern to the subject’s health or well-being and may 
require medical intervention and/or close follow-up. 
13.4.3 Severe 
The event interferes considerable with the subject’s usual activities. The event is of definite 
concern to the subject and/or poses substantial risk to the subject’s health or well-being. 
The event is likely to require medical intervention and/or close follow-up and may be 
incapacitating or life threatening. Hospitalization and treatment may be required. 
Note:  The term “severe” refers to the intensity of the event and can be used with any 
event, without regard to whether or not it meets the criteria for being classified as “serious” 
or “unanticipated”.  For example, a subject can have a severe headache, but it is not a 
serious event.  
13.5 Outcome Definitions 
The outcome is reported in relationship to the Adverse Event, not the treatment rendered 
for the event (if any). 
13.5.1 Resolved 
This outcome indicates the event has improved or recuperated.   
13.5.2 Resolved with Sequelae 
This outcome indicates the subject recuperated but retained pathological conditions 
resulting from the prior disease or injury.  
13.5.3 Resolving* 
This outcome indicates that the event is improving. 
13.5.4 Not Resolved* 
This outcome indicates that the adverse event has not improved or recuperated.  
13.5.5 Fatal* 
The adverse event resulted in the termination of life. 
13.5.6 Unknown* 
The outcome of the adverse event is not known, not observed, not recorded, or patient 
refused to provide information to make an outcome determination. 
 
*Per Regulation (EU) 2017/745 [3], all serious adverse events will be classified according 
to event status outlined in MDCG 2020-10/1 [4] when used to support MDR reporting 
requirements. These event statuses include Resolved, Resolved with Sequelae, Death, 

 
 
 
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and On-going. In order to comply with this reporting requirement, all serious adverse 
events or Device Deficiency (DD) with outcomes classified as ‘Resolving’, ‘Not Resolved’, 
or ‘Unknown’, will be reclassified as ‘On-going’ and all serious adverse events classified 
as 'Fatal' will be reclassified as 'Death'. 
14 Monitoring 
Prior to initiating the clinical study, the Sponsor may conduct a site evaluation visit to ensure 
the Investigator and study staff understands the study protocol and requirements and have 
adequate time and resources to implement and conduct the study. Prior to study initiation,EC 
approval and a fully executed CTA must be in place.  
This is a post-market study that does not involve investigational products or procedures, and 
there is no physical risks to the patients to be included in the study. Many assessments, such 
as the Harris Hip Score were used as standard-of-care for this patient population and do not 
require special training for their use in the study. As such, site initiation visits may be 
conducted remotely for this study. 
During the course of the study, the Sponsor would conduct periodic central monitoring if 
necessary and maintain contact with the study staff to monitor compliance and evidence of 
adverse events, in accordance with the Sponsor’s policies and procedures. The Sponsor will 
address any identified non-compliance with the executed CTA, study protocol, and applicable 
regulatory requirements. 
If onsite monitoring visit(s) are deemed appropriate by the Sponsor, the Investigator will permit 
representatives of the Sponsor’s monitoring team to have direct access to inspect all source 
data/documents, study documents/binders, study subject forms, database, corresponding 
sections of study subject medical/hospital records, and any other documents relevant to the 
study.   
Additional details are provided in the Monitoring plan. 
15 Risk Analysis 
A discussion of the different types of risks and benefits involved with participation in the 
investigation, including, but not limited to: 
15.1 General  
Since all patients have already been operated with the study device and data is only collected 
retrospectively, there are no anticipated risks specific to study participation. There are no experimental 
procedures in this study, and participation in this study is not anticipated to affect the medical treatment 
of included subjects.  
When used in accordance with product labelling, the risks associated with the use of the Zimmer 
Reconstruction System are similar to those of standard, stainless steel systems used for the same 

 
 
 
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clinical indication or purpose. These risks are either surgical risks or risks associated with the subject 
procedure/study device. Unanticipated adverse events can also occur. 
A list of adverse events (AE) and anticipated adverse device effects (ADE) can be found in the 
Instruction for Use of the system (see “Adverse Effects” section). Investigators should refer to it. 
 
15.2 Indemnification 
The indemnification provision is located in the Indemnification section of the executed CTA. 
If an injury is caused to a patient as a result of procedures undertaken in accordance with the Study, 
the Sponsor is liable for damages resulting from the Study. Zimmer GmbH maintains product liability 
and excess liability insurance coverage through its parent company Zimmer Holdings, Inc. 
 
16 Statistical Methods 
16.1 Sample Size Calculation 
The overall success rate of the Zimmer Reconstruction System will be calculated based on the 
percentage of subjects who have successful fracture healing. The following hypothesis will be tested 
by exact binomial test  
 
 
H0: E1 – E0 ≤ - δE 
 
Ha: E1 – E0 > - δE 
 
 
Where:  
E0 = 90%, the expected success rate of similar devices to the Zimmer Reconstruction System [13]  
E1 = the success rate in the Zimmer Reconstruction System treatment group  
δE = 0.10, non-inferiority margin for fracture healing 
 
In addition, one-sided 95% exact confidence Interval (CI), lower limit of the success rate, will be 
calculated. 
 
The sample size was estimated based on the expected performance of 90% fracture union rate. The 
sample size includes a 10% non-inferiority margin (90% - 10% = 80%). The expected Clinical 
Performance Rate of the Zimmer Reconstruction System is assumed as 90%.  
 
Based on the hypothesis test above, a sample size of n = 83 will provide approximately 80% power 
for the one-sided exact binomial test at 0.05 significant level. The sample size was calculated using 
SAS for Windows version 9.4. The aim of this study is to include a total number of 83 cases treated 
between 2010 and 2018 with implants of the Zimmer Reconstruction System at the Azienda 
Ospedaliero Universitaria Senese in Siena, Italy. 
 
16.2 General Statistical Methods 

 
 
 
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Data collected in the study will be summarized descriptively. Descriptive summaries will be the basis 
of study reports to participants, as well as to generate an overall summary of the clinical and 
radiological evaluation of the Zimmer Reconstruction System described in this protocol. 
Continuous data (e.g. age) will be summarized through means, medians, standard deviation, 
minimum, maximum and 95% confidence intervals (CIs) over time periods of interest. Categorical data 
(e.g. gender) will be summarized using counts, percentages and 95% confidence limits over time 
periods of interest. Summaries of fracture healing rate and complication data will be presented as 
frequencies and percentages. Subgroup summaries will be generated as needed either by strata within 
the study population (e.g. male vs. female) or by different cut-points (e.g. body mass index (BMI) 
ranges).  
17 Quality Control & Quality Assurance 
The study is conducted in accordance with the ISO 14155:2020 [1] and the Declaration of 
Helsinki [2].  
The Investigator will be required to permit representative(s) of the Sponsor’s monitoring team 
to inspect the database and corresponding sections of the study patients’ office records and/or 
hospital original medical records. These audits will be done for quality assurance purposes, 
i.e. verifying adherence to the Clinical Investigation Plan and the completeness and accuracy 
of the data being entered on the database. 
The Clinical Investigation Plan will be provided to the participating study center. The 
Investigators will be fully trained in the proper reporting and submission of trial data prior to 
patient enrolment. The completion of the database, database data quality, and data queries 
management for missing or unclear data performed before the statistical evaluation is 
responsibility of the investigator, since the sponsor will have access only to anonymized final 
data. 
There are regular meetings between the Investigators and Zimmer Biomet Clinical Affairs 
staff.  Written correspondence to the site is used to inform the Investigators of routine study 
details and to update them on study status. 
18 Suspension or Premature Termination of the Clinical Investigation 
Zimmer Biomet may decide to suspend or prematurely terminate the clinical study at the 
investigational site if, for example, information becomes available that the data indicates that 
the results significantly differ from the study objectives or statistical endpoints. 
In the case of an early termination of the study, the EC and regulatory authority(ies) should 
be informed in accordance with regional and/or national laws/regulations, and EC 
requirements. The reasons for termination should be provided and documented. 
In case the study got suspended or prematurely terminated before a subject has been 

 
 
 
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included in the study, the study subject shall proceed according to the investigator’s standard 
of care or hospital’s standard procedures. 
19 Vulnerable Populations (as applicable) 
Patients that are within one or more vulnerable populations, including children and prisoners 
are to be excluded from this study. Due to the retrospective design of the study and the 
reporting of only anonymized data there is no need of a informed consent process, as decided 
by the EC.  
20 Amendments / Modifications to the Clinical Investigation Plan 
The use of waivers from the clinical protocol is prohibited. All amendments to this clinical 
protocol shall be agreed to by the Sponsor and be recorded with a justification for the 
amendment prior to implementation. Approval from the EC must be obtained prior to 
implementation of the amended protocol, if required by regional and/or national 
laws/regulations. In the case of an amendment to the protocol, the revision history will be 
documented in the Document History section of this protocol. 
21 Publication Policy 
Both the Principal Investigator and the Sponsor have the right to publish or allow the results 
of the clinical study to be published. The Principal Investigator recognizes that the Sponsor 
has a special interest in the results of the clinical study and will submit manuscripts or final 
reports to the Sponsor prior to publication. If the Sponsor desires changes to be made, these 
are communicated to the Principal Investigator within 30 days of submission. Pooled data may 
be used for training and meetings.  
 
 
 
 
 
 
 
 

 
 
 
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22 Signatures 
Herewith, the undersigned certify that they have read and examined the present protocol 
carefully and declare that they are in agreement with the demands and conditions noted. They 
hereby consent that they will perform the study according to the requirements of the 
Declaration of Helsinki and the ISO 14155:2020, as well as according to any regional or 
national regulations, as appropriate. 
Study Manager (Name and job title/ Date/ Signature) 
Brian Brissoni, Clinical Research 
Associate  
 
 
Head of Clinical Affairs or designee (Name and job title/ Date/ Signature) 
Hassan Achakri, Clinical 
Operations Director 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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23 References 
1. Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice. s.l. : ISO 
14144:2020, 2011. 
2. WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI, Ethical Principles for Medical 
Research Involving Human Subjects. Seoul : 59th WMA General Assembly, October 2008. 
3. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 
April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and 
Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC 
4. MDCG 2020-10/1 Safety reporting in clinical investigations for medical devices under the Regulation 
(EU) 2017/74 
5. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold 
arthroplasty. An end-result study using a new method of result evaluation. Harris, W.H. 4, s.l. : Journal 
of Bone & Joint Surgery, 1969, Bd. 51. p. 737-755. 
6. Trauma, Americal College of Surgeons Committe on. National Trauma Data Bank 2016 Annual 
Report. 2016. 
7. Functional outcome of patients with unstable pelvic ring fractures stabilized with open reduction and 
internal fixation. Gruen, GS., Leit, M.E., Gruen, R.J., Garrison, H.G., Auble, T.E., Peitzmann, A.B. , 
s.l. : The Journal of Trauma, 1995, Bd. 39. p. 838-844. 
8. Comminuted fractures of the iliac wing. Switzer, J.A., Nork, S.E., Routt, M.L.Jr. 4, s.l. : Journal of 
Orthopaedic Trauma, 2000, Bd. 14. p. 270-276. 
9. Pelvic ring injuries: classification and treatment. Gray, A., Chandler, H., Sabri, O. 2, s.l. : 
Orthopaedics and Trauma, 2018, Bd. 32. p. 80-90. 
9. Pelvic disruption: assessment and classification. Pennal, G.F., Tile, M., Waddell, J.P., et al. s.l. : 
Clinical Orthopaedics and Related Research, 1980, Bd. 151. p. 12-21. 
11. Fracture and Dislocation Classification Compendium. Meinberg, E., Agel, J., Roberts, C., et al. 1, 
s.l. : Journal of Orthopaedic Trauma, 2018, Bd. 32. Supplement, January 2018. 
12. Fractures of the Acetabulum: Classification and Surgical Approaches for Open Reduction. Judet, 
R., Judet, J., Letournel, E. 8, s.l. : The Journal of Bone and Joint Surgery, 1964, Bde. 46-A. p. 1615-
1646. 
13. Zimmer Reconstruction System PMSP_WAR_TM_008 Rev 1 
 

 
 
 
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24 Appendices  
A. Study Logs 
B. List of Investigators 
C. List of all applicable Instruments  
D. Investigator’s Consent to the Clinical Investigation Plan