MAUDE Adverse Event Report: EXACTECH, INC. COCR FEM HEAD 32MM -3.5 OFFSET 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	COCR FEM HEAD 32MM -3.5 OFFSET 12/14
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitants: 101-05-03 - drill bit 1 pk 4.5mm dia x 32mm lng, (b)(6).160-10-13 - pf stem taper plasma h/a sz 13, (b)(6).180-01-48 - nv crown cup clstr hole 48mm group 1, 2571001.(b)(6) - alteon 6.5mm screw, 20mm, (b)(6).180-65-25 - alteon 6.5mm screw, 25mm, (b)(6).
Event or Problem Description
It was reported via legal documentation that a patient had a left total hip arthroplasty on (b)(6) 2016, and then experienced revision surgical procedure on (b)(6) 2021, approximately 5 years and 5 months after initial implant.No images were provided.There is no other information available.

• Brand Name: COCR FEM HEAD 32MM -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
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21708553
• Report Number: 1038671-2025-01678
• Device Sequence Number: 4656788
• Product Code: JDI
• UDI-Device Identifier: 10885862026880
• UDI-Public: 10885862026880
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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: 02/07/2021
• Device Model Number: COCR FEM HEAD 32MM -3.5 OFFSET 12/14
• Device Catalogue Number: 142-32-93
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 03/27/2025
• Date Device Manufactured: 02/10/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown