MAUDE Adverse Event Report: EXACTECH, INC. COCR FEM HEAD 32MM +0 OFFSET 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	142-32-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 52 months after a right total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, mild osteolysis, wear debris, inflammatory synovium.Revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Concomitant devices: (32135-38h) - flex drill m 3.2x38 hd lenkbar.(5700932) 142-32-00 - cocr fem head 32mm +0 offset 12/14.(6027046) 186-01-52 - integrip cc, cluster 52mm, g2.(6095237) 188-00-04 - wedge plasma s/o sz 4.(s041163) 180-65-20 - alteon 6.5mm screw, 20mm.The product associated with the reported event is within the scope of recall z-1792-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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.
Additional Manufacturer Narrative
1038671-2024-02344 correction: please disregard this report as it was reported in error.Event was previously reported under report #1038671-2024-02344.

• Brand Name: COCR FEM HEAD 32MM +0 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 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 19704762
• Report Number: 1038671-2024-02331
• Device Sequence Number: 3616279
• Product Code: JDI
• UDI-Device Identifier: 10885862026835
• UDI-Public: 10885862026835
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K041906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 10/29/2023
• Device Catalogue Number: 142-32-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Female