MAUDE Adverse Event Report: EXACTECH, INC. COCR FEM HEAD 28MM +3.5 OFFSET 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	COCR FEM HEAD 28MM +3.5 OFFSET 12/14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: novation cfs cem, std, size 13 (cat# 168-50-13).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the exactech hip replacement study, approximately two months post tha, the (b)(6) y/o female patient experienced left hip prosthesis dislocation.The event is possibly related to the device and definitely related to the procedure.Patient was discharged to extended care facility with a walker 3 days postop.Device will not return due to clinical study policy.
Additional Manufacturer Narrative
As reported by the exactech hip replacement study, approximately two months post tha, the 80 y/o female patient experienced left hip prosthesis dislocation.The event is possibly related to the device and definitely related to the procedure.Patient was discharged to extended care facility with a walker 3 days postop.Device will not return due to clinical study policy.Based on review of all available information, there is no evidence to suggest that the reported dislocation and revision are related to any design, manufacturing, or patient related issues.The cause of the dislocation and revision is most likely is related to the patient¿s underlying condition; however, that could not be confirmed.

• Brand Name: COCR FEM HEAD 28MM +3.5 OFFSET 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12046233
• Report Number: 1038671-2021-00304
• Device Sequence Number: 11629146
• Product Code: JDI
• UDI-Device Identifier: 10885862026781
• UDI-Public: 10885862026781
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K041906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2018
• Device Model Number: COCR FEM HEAD 28MM +3.5 OFFSET 12/14
• Device Catalogue Number: 142-28-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 80 YR