BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM

    MDR report key: 19428098 · Received May 30, 2024

    Report

    Report Number
    1038671-2024-01609
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    May 14, 2024
    Report Date
    September 17, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    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

    PENDING EVALUATION. CONCOMITANT DEVICE(S): (B)(6) - 02-010-04-0250 - LOGIC CR FEMORAL POR, LEFT, SZ 5. (B)(6) - 02-012-45-5060 - LGC TIBIAL FIT TRAY CEM SZ 5F / 6T. (B)(6) - 200-02-41 - THREE PEG PATELLA 41MM (B)(6) - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. (B)(6) - 201-78-81 - 3 TROCAR, MOD. HEX 2PK. (B)(6) - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. (B)(6) - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. (B)(6) - 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS. (B)(6) - A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PRESUMED PROSTHESIS WEAR AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. HOWEVER, THE REPORTED FEMORAL LOOSENING CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 66 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMALTY 4 YEARS POST OP. EVERYTHING WAS REVISED DUE TO OSTEOLYSIS/LOOSENING OF FEMUR AS A RESULT OF PATELLA AND TIBIAL INSERT WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING - DISCARDED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149788 LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention