BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 32MM

    MDR report key: 24202077 · Received January 28, 2026

    Report

    Report Number
    1038671-2026-00080
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    June 19, 2023
    Report Date
    January 28, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039590
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: (B)(6), 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T (B)(6), 02-010-04-0220 - LOGIC CR FEMORAL POR, LEFT, SZ 2 (B)(6), 201-78-81 - 3 TROCAR, MOD. HEX 2PK (B)(6), 02-012-51-2009 - LOGIC TIB INSERT IMPL CRC, SZ 2, 9MM. G2: (AUSTRALIA). H10: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1038671-2023-01482. NO DEVICE WAS RETURNED FOR EVALUATION; PHOTOGRAPHS OF THE DEVICE WERE PROVIDED; HOWEVER, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. THE REVIEW IDENTIFIED DEFORMATION/WEAR LIKELY DUE TO ARTICULATING AGAINST THE FEMORAL COMPONENT WHILE IMPLANTED AND WEAR THAT IS CONSISTENT WITH TOOL MARKS CREATED WHILE REMOVING THE COMPONENT. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. THE REVISION REPORTED IN THIS EVENT WAS LIKELY THE RESULT OF PRESUMED PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLA COMPONENT. HOWEVER, IMAGES OF THE REVISED COMPONENTS DO NOT SHOW SIGNS OF EXCESSIVE PROSTHESIS WEAR INCONSISTENT WITH BEING IMPLANTED, NO RADIOGRAPHS WERE PROVIDED, AND THE REVISED COMPONENT WAS NOT RETURNED FOR EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    REPORT #2 OF 2 FOR THIS EVENT: AS REPORTED, APPROXIMATELY TWO (2) YEARS POST AN INITIAL LEFT TOTAL LEFT KNEE ARTHROPLASTY, THIS PATIENT WAS REVISED DUE TO POLY WEAR. THE PATELLA AND TIBIAL INSERT COMPONENTS WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261120 THREE PEG PATELLA 32MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039590

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention| H SEE H11