BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE ANKLE SYSTEM

    MDR report key: 23247505 · Received October 8, 2025

    Report

    Report Number
    1038671-2025-03061
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    July 26, 2021
    Report Date
    October 8, 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: 350-11-03 - TIBIAL PLATE FB SZ 3 LT: (B)(6). 350-21-23 - TIBIAL INSERT FB SZ 3 LT 8MM: (B)(6). 350-01-03 - TALAR IMPLANT SZ 3 LT: (B)(6). 350-10-03 - ANKLE SZ 3 LOCKING CLIP: (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 2 YEARS AND 4 MONTHS POST THE INITIAL LEFT TOTAL ANKLE ARTHROPLASTY, THE PATIENT REPORTED ONGOING PAIN IN THEIR LATERAL ANKLE AND CLICKING OF FOREFOOT. SYMPTOMATIC IMPINGEMENT. THEY ALSO REPORTED PAIN OVER THEIR FIRST TMT JOINT, WHICH WAS FUSED. HARDWARE WILL BE REMOVED, AND ARTHROSCOPIC DEBRIDEMENT OF THE LATERAL AND MEDIAL GUTTERS WILL BE PERFORMED. ACTIONS TAKEN WERE A LEFT ANKLE ARTHROSCOPY WITH EXTENSIVE DEBRIDEMENT OF THE LATERAL MALLEOLUS, PARTIAL REMOVAL OF TALUS, FLUROSCOPY, AND REMOVAL OF DEEP HARDWARE IN LEFT MIDFOOT. THE OUTCOME IS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2663025 VANTAGE ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other SEE H11.