BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR FEMORAL POR, LEFT, SZ 5

    MDR report key: 19990344 · Received August 15, 2024

    Report

    Report Number
    1038671-2024-02853
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    November 2, 2023
    Report Date
    November 21, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862158284
    PMA / PMN Number
    K123687
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: (B)(6), - 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T, (B)(6), - 200-02-38 - THREE PEG PATELLA 38MM, (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

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. 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 AND FEMORAL LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS WERE NOT PROVIDED. CORRECTION: D10 CONCOMITANT. D10: (B)(6) - 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. (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.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS AND 3 MONTHS POST THE INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO POLY WEAR AND FEMUR LOOSENING. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895103 LOGIC CR FEMORAL POR, LEFT, SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862158284

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention SEE H11.| SEE H11.