BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 1902410 · Received November 12, 2010

    Report

    Report Number
    3003640913-2010-00032
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 12, 2010
    Manufacturer
    WALDEMAR LINK, GMBH & CO
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIABETIC PT WITH WOUND INFECTION. SURGEON WILL REVISE IN 6-8 WEEKS AFTER INFECTION HAS RESOLVED. NO MALFUNCTION OF THE DEVICE WAS INDICATED.

    Description of Event or Problem · 1

    PT HAD STAR ANKLE IMPLANT EXPLANTED DUE TO WOUND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAR TOTAL ANKLE REPLACEMENT TOTAL ANKLE PROSTHESIS NTG WALDEMAR LINK, GMBH & CO 400-263 090807/2187

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention