BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 19829597 · Received July 25, 2024

    Report

    Report Number
    1038671-2024-02538
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    March 25, 2024
    Report Date
    July 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    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: CONCOMITANTS: LGC TIBIAL FIT TRAY CEM SZ 3.5F / 4.5T - 02-012-45-3545 - 4869480 LOGIC CR FEMORAL POR, LEFT, SZ 3.5 - 02-010-04-0235 - 4416761 THREE PEG PATELLA 38MM - 200-02-38 - 6067814. THE REVISION REPORTED WAS LIKELY THE RESULT OF PRESUMED PROSTHESIS WEAR OF THE TIBIAL INSERT AND THE PATELLA, AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED, A 64 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2022, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 1 YEAR 7 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO FEMUR LOOSING FROM POLY AND PATELLA WEAR. EVERYTHING WAS REMOVED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAY DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS PROVIDED. NO DEVICES RETURNING FOR ANALYSIS. THEY WERE DISCARDED AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS WAS THE 2ND REVISION FOR THIS PATIENT. 1ST REVISION REPORTED UNDER MDR# 1038671-2022-01115.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254810 OPTETRAK PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention SEE H11