BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE ANKLE COMPONENTS

    MDR report key: 21839830 · Received April 15, 2025

    Report

    Report Number
    1038671-2025-01809
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 15, 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

    (D10) CONCOMITANT DEVICES: 03-CMB-LC-0004 - P/P+ LOCKING CLIP - SZ4. 03-PML-10-0004 - PRIM+ TIB-L-20MM-SZ4. 350-01-04 - TALAR IMPLANT SZ 4 LT. 350-23-44 - VIT E LINER-L-SZ 4-10MM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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 EXPERIENCED PAIN ON LOWER LEFT EXTREMITY. EXAM SHOWS CR < 3 SEC, DISTAL SENSATION/MOTOR FUNCTION NORMAL. SKIN BREAKDOWN AT CONTACT POINT WITH CAST OVER SHIN. COMPARTMENTS SOFT. NO OTHER SKIN CHANGES. PATIENT STABLE. WORK UP CONSISTENT WITH UNDIFFERENTIATED LEG PAIN. DO NOT SUSPECT DVT, COMPARTMENT SYNDROME, OR INFECTION. AS A RESULT, APPROXIMATELY 7 DAYS AFTER INITIAL REPLACEMENT, THE PATIENT WAS ADMINISTERED MEDICATION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111997 VANTAGE ANKLE COMPONENTS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male SEE H11