BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 41MM

    MDR report key: 24779435 · Received April 3, 2026

    Report

    Report Number
    1038671-2026-00369
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    October 19, 2022
    Report Date
    April 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039620
    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: 02-012-48-4009 - LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM: SN# (B)(6). 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T:SN# (B)(6). 02-010-04-0340 - LOGIC CR FEMORAL POR, RIGHT, SZ 4: SN# (B)(6). H10: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2022-01446, 1038671-2026-00368. THE REVISION REPORTED WAS LIKELY THE RESULT OF FEMORAL LOOSENING AND PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLA COMPONENT. THE WEAR MAY HAVE BEEN DUE TO A COMBINATION OF THIRD BODY WEAR, POSITIONING OF THE COMPONENTS, AND/OR PATIENT RELATED CONDITIONS. THE REPORTED LOOSENING MAY HAVE BEEN DUE TO AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING OF THE FEMORAL COMPONENT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED. IT IS UNCLEAR IF THE REPORTED LOOSENING MAY HAVE CONTRIBUTED TO THE WEAR OR IF THE WEAR MAY HAVE CONTRIBUTED TO THE REPORTED LOOSENING. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED FEMORAL LOOSENING SECONDARY TO TIBIAL AND PATELLA POLYETHYLENE WEAR. AS A RESULT, APPROXIMATELY FOUR YEARS EIGHT MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 FOR THIS EVENT/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841769 THREE PEG PATELLA 41MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039620

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| H