BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE ANKLE COMPONENTS

    MDR report key: 23294977 · Received October 15, 2025

    Report

    Report Number
    1038671-2025-03111
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    December 28, 2020
    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: 350-11-03 - 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)96), 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL ANKLE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND EXTRASKELETAL OSSIFICATION DESPITE EXCELLENT CONDITION OF THE ARTHROPLASTY IN RADIOGRAPHS. AS A RESULT, THE PATIENT UNDERWENT LEFT SUBTALAR ARTHRODESIS AND PARTIAL REMOVAL LEFT 5TH METATARSAL HEAD APPROXIMATELY 2 YEARS AND 1 MONTH AFTER INITIAL SURGERY. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535978 VANTAGE ANKLE COMPONENTS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11