BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE ANKLE COMPONENTS

    MDR report key: 21901858 · Received April 24, 2025

    Report

    Report Number
    1038671-2025-01886
    Event Type
    Injury
    Date Received
    April 24, 2025
    Date of Event
    July 16, 2024
    Report Date
    April 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 350-11-03 - TIBIAL PLATE FB SZ 3 LT: (B)(6), 350-21-12 - TIBIAL INSERT FB SZ 2 LT 7MM: (B)(6), 350-01-02 - TALAR IMPLANT SZ 2 LT: (B)(6), 350-10-03 - ANKLE SZ 3 LOCKING CLIP: (B)(6). 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. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL ANKLE REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED SEVERE PAIN POST ANKLE ROLLING INCIDENT. AS A RESULT, APPROXIMATELY 6 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A LEFT ANKLE REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290274 VANTAGE ANKLE COMPONENTS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization SEE H11