BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL PLATE MB SZ 3 RT

    MDR report key: 21217790 · Received January 23, 2025

    Report

    Report Number
    1038671-2025-00357
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    January 1, 2025
    Report Date
    January 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: (B)(6), 350-42-42 - TIBIAL INSERT MB SZ 2 RT 10MM; (B)(6), 351-90-20 - TUBERCLE PIN POUCH; (B)(6), 350-02-02E - TALUS -RIGHT- SZ 2 - EU; (B)(6), 351-90-24 - TALAR TRIAL SCREW POUCH; (B)(6), 351-90-22 - 2.5 PIN POUCH; (B)(6), 350-32-03 - TIBIAL PLATE MB SZ 3 RT; (B)(6), 351-90-21 - 3.5 PIN POUCH. H3: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S LEFT ANKLE WAS REVISED APPROXIMATELY 3 MONTHS POST OP. PATIENT PRESENTED WITH INFECTION. TIBIAL INSERT WAS REPLACED, TIBIAL PLATE AND TALAR COMPONENT WERE RETAINED. THE TIBIAL COMPONENT FOR THE RIGHT PROTHESIS HAD LOST FIXATION FROM SURROUNDING BONE, MOST LIKELY DUE TO INFECTION. ALL PROTHESIS FROM THE RIGHT SIDE WERE REMOVED, AND A CEMENT BLOCK WAS PUT IN LEU UNTIL ADEQUATE REVISION COULD TAKE PLACE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953264 TIBIAL PLATE MB SZ 3 RT PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention