BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE FIXED BEARING ANKLE COMPONENTS

    MDR report key: 25111387 · Received May 7, 2026

    Report

    Report Number
    1038671-2026-00549
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    September 10, 2025
    Report Date
    May 7, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 03-PMR-15-0003 - PRIM+ TIB-R-15MM-SZ3: (B)(6), 350-24-23 - VIT E LINER-R-SZ 3-8MM: (B)(6), 350-02-03 - TALAR IMPLANT SZ 3 RT: (B)(6), 03-CMB-LC-0003 - P/P+ LOCKING CLIP - SZ3: (B)(6). 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

    AS REPORTED BY THE EXACTECH VANTAGE TOTAL ANKLE STUDY, APPROXIMATELY 5 DAYS POST THE INITIAL RIGHT TOTAL ANKLE REPLACEMENT, THE PATIENT HAD A VERY STRONG PAIN BEHIND THEIR KNEE AND WAS INSTRUCTED TO COME IN FOR AN EVALUATION. AN ULTRASOUND VASCULAR EXAM FOUND A SUPERFICIAL THROMBOSIS OF A LONG SEGMENT (10CM) IN THE SMALL SAPHENOUS VEIN. THE PATIENT'S MEDICATION WAS SWITCHED AND THEY HAVE EXPERIENCED NO ISSUES SINCE. THE OUTCOME IS CONSIDERED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112147 VANTAGE FIXED BEARING ANKLE COMPONENTS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Hospitalization| R SEE H11