BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM

    MDR report key: 18467592 · Received January 8, 2024

    Report

    Report Number
    1038671-2024-00037
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    November 29, 2023
    Report Date
    November 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174512
    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

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS, 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, OSTEOLYSIS, AND FEMORAL LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS. LOGIC CR FEMORAL POR, RIGHT, SZ 4 (CAT# 02-010-04-0340 / SERIAL# (B)(6). THREE PEG PATELLA 38MM (CAT# 200-02-38 / 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 FIVE YEARS POST INITIAL RIGHT TKA, THE 56 Y/O MALE PATIENT WAS REVISED DUE TO POLYETHELENE WEAR AND FEMORAL LOOSENING, AS A RESULT OF OSTEOLYSIS. THE PATIENT WAS REVISED TO A LOGIC CEM PS FEMUR SIZE 4 AND A SIZE 4 TIBIAL INSERT. THERE WAS BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949638 LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM UNK 10885862174512

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention LGC TIBIAL FIT TRAY CEM SZ 4F / 4T