BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 21994060 · Received May 9, 2025

    Report

    Report Number
    1038671-2025-02014
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    February 7, 2024
    Report Date
    May 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039606
    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: 3766400 - 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4. 3586776 - 02-012-44-4011 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM. 3795289 - 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. 3832369 - 200-02-35 - THREE PEG PATELLA 35MM. H3 - THE REVISION REPORTED MAY HAVE BEEN DUE TO ORIENTATION OF THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, INSTABILITY, OR ANY COMBINATION OF THESE WHICH LED TO WEAR OF THE TIBIAL INSERT AND PATELLA COMPONENT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 82 YO MALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY WEAR AS WELL AS FLAKING AND DELAMINATION. THE PATIENT WAS REVISED TO A 38MM PATELLA, AND THE TIBIAL INSERT WAS REVISED TO A SZ 4, 11MM. FRAGMENTS OF POLYETHYLENE WERE PRESENT IN THE KNEE JOINT WHICH THE SURGEON REMOVED. X-RAYS WERE PROVIDED. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THE SURGEON KEPT THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946699 OPTETRAK PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039606

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention SEE H11