BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE ANKLE COMPONENTS

    MDR report key: 22731853 · Received August 6, 2025

    Report

    Report Number
    1038671-2025-02697
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 28, 2025
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS). THE REASON FOR THE REPORTED REVISION DUE TO SUSPECTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10: (B)(6) - 03-PML-20-0005 - PRIM+ TIB-L-20MM-SZ5, (B)(6) - 350-23-24 - VIT E LINER-L-SZ 4-8MM, (B)(6) - 03-CMB-LC-0005 - P/P+ LOCKING CLIP - SZ5, (B)(6) - 350-01-04 - TALAR IMPLANT SZ 4 LT. 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 LEFT SIDE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO PROSTHETIC JOINT INFECTION. THE TIBIAL LINER AND LOCKING CLIP WERE REPLACED WITH EXACTECH DEVICES. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766170 VANTAGE ANKLE COMPONENTS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| H