MAUDE Adverse Event Report: EXACTECH, INC. COCR FEM HEAD 36MM +3.5 OFFSET 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	COCR FEM HEAD 36MM +3.5 OFFSET 12/14
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: wedge plasma x/o sz 5 (cat# 188-01-05 / serial# (b)(4)).The evaluation noted that revision reported was likely the result of either under sizing the femoral stem for the patients anatomy/femoral bone or insufficient bony support for the implant, possibly due to a patient-related condition, which led to femoral stem subsidence.However, this cannot be confirmed as the explants were not available for evaluation and x-ray images were not provided.The most probable root cause associated with the reported event of "femoral stem subsidence" is associated with a femoral stem that subsides into the prepared femoral canal further than expected.This can occur during implantation or post-operatively.
Event or Problem Description
Approximately 3 mos.Postop the initial implant, this (b)(6) y/o patients original tapered wedge stem subsided so a revision right hip surgery was needed.The surgeon removed the alteon tapered press fit stem and cocr head were removed and a new nv cemented plus stem size 13, 13mm cemented stem centralizer, and new cocr 36mm +0 offset was implanted.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to the hospital policy.

• Brand Name: COCR FEM HEAD 36MM +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: 11761522
• Report Number: 1038671-2021-00209
• Device Sequence Number: 17268908
• Product Code: JDI
• UDI-Device Identifier: 10885862250940
• UDI-Public: 10885862250940
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: COCR FEM HEAD 36MM +3.5 OFFSET 12/14
• Device Catalogue Number: 142-36-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2021
• Initial Report FDA Received Date: 05/03/2021
• 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: 81 YR
• Patient Weight: 57