BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 1910536 · Received November 24, 2010

    Report

    Report Number
    3003640913-2010-00034
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 24, 2010
    Manufacturer
    WALDEMAR LINK, GMBH & CO.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POLY CORE RETURNED FOR EVAL. EVAL CONFIRMED SURGERY REPORT OF BROKEN POLY DUE TO THE PT'S FALL.

    Description of Event or Problem · 1

    PT TRIPPED AND FELL. POLY CORE WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention