BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR FEMORAL CEM, LEFT SZ 2

    MDR report key: 19427847 · Received May 30, 2024

    Report

    Report Number
    1038671-2024-01605
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    April 18, 2024
    Report Date
    September 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION, (D10) CONCOMITANT DEVICE(S): 4632315 - 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T. 6896919 - 200-02-35 - THREE PEG PATELLA 35MM. 6176661 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 6837191 - 201-78-81 - 3 TROCAR, MOD. HEX 2PK. S337427 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S337437 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 4579701 - 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS. 9000221286 - A10012 - GPS IMPLANT KIT V2. 6108425 - 02-012-51-2009 - LOGIC TIB INSERT IMPL CRC, SZ 2, 9MM.

    Additional Manufacturer Narrative · 0

    (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PRESUMED POLYETHYLENE WEAR AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH MAY HAVE LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. HOWEVER, THE REPORTED FEMORAL LOOSENING COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) HEALTH EFFECT - CLINICAL CODE: 2377, OSTEOLYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 60 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 2 YEARS POST OP. FEMUR AND TIBIA WERE REVISED DUE TO OSTEO-LYSIS AND FEMORAL LOOSENING. SURGEON REMOVED ALL EXACTECH DEVICES AND PUT ANOTHER COMPANIES PRODUCT IN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225050 LOGIC CR FEMORAL CEM, LEFT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention SEE H10.