BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,

    MDR report key: 20536452 · Received October 25, 2024

    Report

    Report Number
    1038671-2024-04129
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    September 5, 2023
    Report Date
    October 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862061744
    PMA / PMN Number
    K032606
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANTS: 2155075 200-05-26 - INSET PATELLA 26MM, 2281536 230-03-02 - OPTETRAK ASY, CR CEMENTED FEMORAL, SZ 2, 2311025 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T. THE REASON THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. THE REPORTED FEMORAL LOOSENING MAY HAVE BEEN THE RESULT OF FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE, WHICH LED TO LOOSENING AT THE CEMENT-IMPLANT INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED AS THERE WERE NO DETAILS REGARDING CEMENTING TECHNIQUE OR ENVIRONMENTAL CONDITIONS PROVIDED. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    LEGAL CASE-USA. PATIENT ID: (B)(6). IT WAS REPORTED THAT APPROXIMATELY 136 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SCAR TISSUE AND SYNOVITIS. OP REPORT NOTED POLY HAD SEVERE WEAR PATTERN AND PULSED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL NUMBER, ITEM NUMBER AND FULL DESCRIPTION (B)(6), 200-72-09 - CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++ SERIAL NUMBER: (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K082022. CONCOMITANTS: 2155075 200-05-26 - INSET PATELLA 26MM, 2281536 230-03-02 - OPTETRAK ASY, CR CEMENTED FEMORAL, SZ 2, 2311025 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795906 OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2, PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862061744

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| R SEE H11.