BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE ANKLE COMPONENTS

    MDR report key: 23294899 · Received October 15, 2025

    Report

    Report Number
    1038671-2025-03112
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    January 26, 2018
    Report Date
    October 14, 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: 350-01-03 - TALAR IMPLANT SZ 3 LT 5184255. 350-10-04 - ANKLE SZ 4 LOCKING CLIP: 5165692. 350-11-04 - TIBIAL PLATE FB SZ 4 LT 5203654. 350-21-23 - TIBIAL INSERT FB SZ 3 LT 8MM 4536676. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 LEFT TOTAL ANKLE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO FLEX THEIR LEFT GREAT TOE. THE SURGEON STATED THAT THE FHL (FLEXOR HALLUCIS LONGUS) TENDON MAY HAVE BEEN INJURED DURING THE PROCEDURE. NO INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004140 VANTAGE ANKLE COMPONENTS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Disability