BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE ANKLE COMPONENTS

    MDR report key: 23302546 · Received October 15, 2025

    Report

    Report Number
    1038671-2025-03116
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    December 16, 2020
    Report Date
    February 10, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D1, D4, D10, G4, H6. D10: 350-42-02 - TIBIAL INSERT MB SZ 2 RT 6MM. 350-32-02 - TIBIAL PLATE MB SZ 2 RT. 350-02-02E - TALUS -RIGHT- SZ 2 - EU.

    Additional Manufacturer Narrative · 0

    D10: 350-32-02 - TIBIAL PLATE MB SZ 2 RT, 350-02-02E - TALUS -RIGHT- SZ 2 - EU. 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 TOTAL ANKLE REPLACEMENT ON THE RIGHT SIDE. APPROXIMATELY 2 YEARS 4 MONTHS POST OPERATION, THE PATIENT EXPERIENCED PERIARTICULAR OSSIFICATION AND ANKLE INSTABILITY REQUIRING A REVISION OF THE TIBIAL INSERT. SURGEON ALSO PERFORMED A RESECTION OF MEDIAL PERIARTICULAR OSSIFICATION AND A DELTOID LIGAMENT RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357689 VANTAGE ANKLE COMPONENTS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization SEE H11