BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM

    MDR report key: 17358302 · Received July 20, 2023

    Report

    Report Number
    1038671-2023-01708
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 29, 2023
    Report Date
    November 15, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159144
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: FEMORAL COMPONENT CR, POROUS SIZE 2.5, 02-010-04-0225 4182492. FIT TIBIAL TRAY CEMENTED SIZE 2.5F/2.5T 02-012-45-2525 4333636. THREE PEG PATELLA, 35MM 200-02-35 4458694. H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H3: THE REASON FOR THE REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY BE DUE TO A COMBINATION OF PROSTHESIS WEAR AS REPORTED, PATIENT CONDITIONS, OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2016. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765141 LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-47-2509 10885862159144

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention