BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE

    MDR report key: 22801004 · Received August 13, 2025

    Report

    Report Number
    1038671-2025-02754
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 18, 2025
    Report Date
    September 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862302021
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: (B)(6), 350-01-04 - TALAR IMPLANT SZ 4 LT, (B)(6), 350-11-04 - TIBIAL PLATE FB SZ 4 LT, (B)(6), 351-50-00 - MODEL TIBIA TALUS REPORT, (B)(6), 351-90-21 - 3.5" PIN POUCH, (B)(6), 351-90-21 - 3.5" PIN POUCH, (B)(6), 351-90-22 - 2.5" PIN. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION PERTAINING TO THIS EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. AS A RESULT, THIS COMPLAINT EVENT IS NO LONGER CONSIDERED REPORTABLE BY EXACTECH AND THIS REPORT MAY BE DISREGARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 72 YO MALE PATIENT, WHO HAD THEIR LEFT ANKLE IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE TIBIAL CLIP WAS FOUND ON A LATERAL X-RAY TO BE COMING OUT OF THE POLY. THE POLY WAS EXCHANGED WITH A NEW TIBIAL CLIP. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686937 VANTAGE PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. 10885862302021

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention SEE H11.