BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 2, 9MM

    MDR report key: 19892840 · Received August 2, 2024

    Report

    Report Number
    1038671-2024-02652
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 12, 2024
    Report Date
    December 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K123342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 5897486 02-010-03-0220 - LOGIC CR FEMORAL CEM, LEFT SZ 2. 2432888 02-012-42-2008 - LOGIC PTS, SIZE 2, 8MM. 5945482 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T. 6293128 200-05-29 - INSET PATELLA 29MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 63 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN (B)(6) 2020, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 4 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON WITH COMPLAINTS OF PAINT, INSTABILITY, AND DISSATISFACTION. THEY WERE SCHEDULED FOR A KNEE REVISION VS POLY SWAP AND THE PATIENT WAS REVISED TO A TRULIANT TIB IMP CRC INSERT SZ 2, 11MM SN: (B)(6). THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY IMAGE WAS PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR ANALYSIS AS IT WAS DISCARDED BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216345 LOGIC TIB INSERT IMPL CRC, SZ 2, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention SEE H11