BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM

    MDR report key: 18083428 · Received November 7, 2023

    Report

    Report Number
    1038671-2023-02698
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    October 17, 2023
    Report Date
    November 21, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230447
    PMA / PMN Number
    K123342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 6262512 02-010-04-0235 - LOGIC CR FEMORAL POR, LEFT, SZ 3.5 6455568 02-012-45-3525 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T 6547748 200-02-35 - THREE PEG PATELLA 35MM.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2.5 YEARS POST OP INITIAL LEFT TKA, THIS 78 Y/O FEMALE PATIENT WAS REVISED DUE POLY WEAR. EVERYTHING WAS REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING EVENT. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING: DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120356 LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862230447

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female