BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 6, 9MM

    MDR report key: 18812560 · Received February 29, 2024

    Report

    Report Number
    1038671-2024-00351
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 29, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174680
    PMA / PMN Number
    K121307
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS LOGIC CR FEMORAL POR, RIGHT, SZ 6 (CAT# 02-010-04-0360 / SERIAL# (B)(6); LGC TIBIAL FIT TRAY CEM SZ 6F / 6T (CAT# 02-012-45-6060 / SERIAL# (B)(6); THREE PEG PATELLA 41MM (CAT# 200-02-41 / SERIAL# (B)(6). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 8.5 YEARS POST INITIAL RIGHT TKA, THE MALE PATIENT PRESENTED TO SURGEON WITH A SORE KNEE. THE SURGEON DEALT WITH THE KNEE WITH SUSPICION DUE TO THE PREVIOUS TGA NOTIFICATIONS AND ONGOING ISSUE WITH THE KNEE INSERTS. THE SURGEON DECIDED TO REMOVE ALL IMPLANTS AND REPLACE WITH A COMPETITOR'S REVISION KNEE SYSTEM. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212085 LOGIC CR TIB INSERT SLOPE+, SZ 6, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 6, 9MM UNK 10885862174680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention