BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE ANKLE COMPONENTS

    MDR report key: 24093127 · Received January 16, 2026

    Report

    Report Number
    1038671-2026-00053
    Event Type
    Injury
    Date Received
    January 16, 2026
    Date of Event
    June 30, 2023
    Report Date
    January 16, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 - CONCOMITANTS: 350-11-04 - TIBIAL PLATE FB SZ 4 LT: 6395668. 350-01-02 - TALAR IMPLANT SZ 2 LT: 6706278. 350-10-04 - ANKLE SZ 4 LOCKING CLIP: 6624537. 350-21-62 - TIBIAL INSERT FB SZ 2 LT 12MM: 6143360. THE REASON FOR THE CLINICAL SYMPTOM OF PAIN REPORTED IN CANNOT BE CONCLUSIVELY DETERMINED AND THE EVENT CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, AND RADIOGRAPHS WERE NOT PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH VANTAGE TOTAL ANKLE STUDY, APPROXIMATELY 2 YEARS AND 6 MONTHS POST THE INITIAL LEFT TOTAL ANKLE REPLACEMENT, AND 2 WEEKS POST THEIR SINUS TARSI INJECTION, THE PATIENT RETURNED FOR A FOLLOW UP AND STATES THEY DID NOT GET ANY PAIN RELIEF, EVEN TEMPORARILY, WITH THE SHOT. THE SUBJECT IS MOSTLY TENDER OVER THE POSTERIOR TIBIAL TENDON. THE PATIENT WAS GIVEN A REFERRAL FOR CONSIDERATION OF OPEN DEBRIDEMENT AND FLEXOR DIGITORUM LONGUS TENDON TRANSFER. THE OUTCOME IS CONSIDERED TO BE CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155564 VANTAGE ANKLE COMPONENTS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R