BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID TIBIAL TRAY SZ 3F/2T

    MDR report key: 21316093 · Received February 5, 2025

    Report

    Report Number
    1038671-2025-00690
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    May 16, 2017
    Report Date
    February 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862047656
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    1038671-2023-00503 D10: 2386961 - 200-02-35 - THREE PEG PATELLA 35MM, 1203476 - 200-63-11 - CR TIBIAL INSERT SZ 3, 11MM, SLOPE +, 2232807 - 230-02-03 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-00503. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, METAL RELATED PATHOLOGY, DISCOMFORT, PAIN, OSTEOLYSIS, SCAR TISSUE AND SYNOVITIS. INITIAL SURGERY AND 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845897 TRAPEZOID TIBIAL TRAY SZ 3F/2T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862047656

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| R SEE H11.