MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 38MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-38
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint effusion (4849); Aseptic loosening (4883)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 138 months after a right total knee replacement procedure, the patient underwent a revision procedure to address persistent effusions, weightbearing pain, a loose femur and recalled poly.Revision surgery operative notes were provided.Pre-op x-rays showed large effusion and osteolysis around the periphery of the tibial and femoral components.The patella was found to be delaminated with yellow oxidation.The femoral component was found to be grossly loose.The tibial component was well-fixed.The patient was revised to exactech devices.The patient was awakened and taken to recovery room in stable condition.No further issues or complications were reported.Images and x-rays were provided.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) - 02-010-01-0350 - logic femoral ps cem right sz 5.(b)(6) - 02-012-35-5009 - logic tibia ps mod insrt sz 5 9mm.(b)(6) - 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00711, 1038671-2025-02871.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d.The revision reported was likely the result of femoral loosening as reported, prosthesis wear of the patella, and/or due to the inclusion of the polyethylene in the packaging recall.However, the femoral loosening cannot be confirmed from the information provided but may be due to over 10 years of use and/or due to an insufficient bond between the femoral component and cement.Potential contributions of user or patient-related considerations should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: THREE PEG PATELLA 38MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22956617
• Report Number: 1038671-2025-02872
• Device Sequence Number: 12894154
• Product Code: JWH
• UDI-Device Identifier: 10885862039613
• UDI-Public: 10885862039613
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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: 01/03/2016
• Device Catalogue Number: 200-02-38
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2011
• 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; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male