BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 2193244 · Received July 29, 2011

    Report

    Report Number
    3003640913-2011-00018
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    WALDEMAR LINK GMBH & CO.
    Product Code
    HSN
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON REVISED STAR POLY CORE. POLY COMPONENT WAS FRACTURED AFTER 10 YEARS OF USE. REVIEW OF DEVICE HISTORY RECORD SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    PATIENT HAD STAR POLY CORE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAR TOTAL ANKLE REPLACEMENT TOTAL ANKPLE REPLACEMENT HSN WALDEMAR LINK GMBH & CO. 400-140 8002450

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention ACHILLES RELEASE