BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM

    MDR report key: 18052119 · Received November 1, 2023

    Report

    Report Number
    1038671-2023-02654
    Event Type
    Injury
    Date Received
    November 1, 2023
    Date of Event
    October 12, 2023
    Report Date
    April 21, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174611
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    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 D10: CONCOMITANT PRODUCTS: LGC TIBIAL FIT TRAY CEM SZ 5F / 5T (CAT# 02-012-45-5050 / SERIAL# (B)(6)). LOGIC CR FEMORAL POR, LEFT, SZ 5 (CAT# 02-010-04-0250 / 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.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO WEAR OF THE POLYETHYLENE INSERT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED. ADDITIONALLY, THE INSERT WAS PACKAGED IN A NON-CONFORMING VACUUM BAG FOR OVER FIVE YEARS, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED WEAR.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3.5 YEARS POST INITIAL LEFT TKA, THE 70 Y/O MALE PATIENT HAD A REVISION DUE TO POLY WEAR. PATIENT HAD A LINER WAS EXCHANGED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216067 LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM UNK 10885862174611

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention