BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE FIXED BEARING ANKLE COMPONENTS

    MDR report key: 25111324 · Received May 7, 2026

    Report

    Report Number
    1038671-2026-00548
    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-PML-20-0005 - PRIM+ TIB-L-20MM-SZ5: (B)(6), 350-01-04 - TALAR IMPLANT SZ 4 LT: (B)(6), 03-CMB-LC-0005 - P/P+ LOCKING CLIP - SZ5: (B)(6), 350-23-24 - VIT E LINER-L-SZ 4-8MM: (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 1 MONTH AND 13 DAYS POST THE PATIENT'S POLYETHYLENE LINER SWAP REVISION SURGERY, THE PATIENT EXPERIENCED WOUND DEHISCENCE. ACTION TAKEN: MEDICATION. THE OUTCOME IS CONSIDERED TO BE CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115558 VANTAGE FIXED BEARING ANKLE COMPONENTS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization| R SEE H11