MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-35
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the revision reported was likely a combination of instability, rotational mismatch of the components, and patient-related conditions, which led to prosthesis wear and osteolysis.D10: 5405348 02-010-01-0330 - logic femoral ps cem right sz 3.5099711 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.
Event or Problem Description
As reported, the patient had an initial total knee arthroplasty.Subsequently, the surgeon performed a full revision on the patient due to painful synovitis, extensive granuloma, abnormal wear of the pe requiring excision, femoral and tibial osteolysis, and tibial and femoral bone graft.No further information provided.

• Brand Name: THREE PEG PATELLA 35MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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 ; 3523771140
• MDR Report Key: 22440791
• Report Number: 1038671-2025-02437
• Device Sequence Number: 17320542
• Product Code: JWH
• UDI-Device Identifier: 10885862039606
• UDI-Public: 10885862039606
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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: 05/15/2022
• Device Catalogue Number: 200-02-35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male