BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20774762 · Received November 25, 2024

    Report

    Report Number
    1038671-2024-04491
    Event Type
    Injury
    Date Received
    November 25, 2024
    Date of Event
    September 26, 2024
    Report Date
    February 5, 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

    PENDING INVESTIGATION. D10: 350-31-02 - TIBIAL PLATE MB SZ 2 LT (B)(6) 350-01-02 - TALUS - LEFT - SZ 2 - EU (B)(6). 350-41-02 - TIBIAL INSERT MB SZ 2 LT 6MM (B)(6).

    Additional Manufacturer Narrative · 0

    "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE CAUSE OF THE PATIENT¿S INSTABILITY AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE TENSION, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. HOWEVER, THE FAILURE COULD NOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY."

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 YEAR AND 6 MONTHS POST THE INITIAL LEFT ANKLE ARTHROPLASTY, THE PATIENT WAS REVISED TO A FLAT CUT TALUS DUE TO INSTABILITY. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS UNAVAILABLE. EBI ATTACHED. PRODUCTS NOT RETURNING: DISPOSED CONCOMITANTS: 350-31-02 - TIBIAL PLATE MB SZ 2 LT (B)(6). 350-01-02E - TALUS - LEFT - SZ 2 - EU (B)(6). 350-41-02 - TIBIAL INSERT MB SZ 2 LT 6MM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014249 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention| H SEE H11.