BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 2944972 · Received February 1, 2013

    Report

    Report Number
    3003640913-2013-00004
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 1, 2013
    Manufacturer
    WALDEMAR LINK GMBH & CO
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TIBIAL COMPONENT WAS EXCHANGED TO IMPROVE ALIGNMENT. THE SLIDING CORE WAS EXCHANGED AS A MATTER OF OPPORTUNITY. REVIEW OF DEVICE HISTORY RECORDS SHOWS NO ANOMALIES. ADDITIONAL MODEL #: 400-141, ADDITIONAL LOT NUMBER: 1002121, ADDITIONAL EXPIRATION DATE: 12/01/2016, ADDITIONAL DEVICE MANUFACTURE DATE: 12/01/2011.

    Description of Event or Problem · 1

    PT HAD STAR SLIDING CORE BEARING AND TIBIAL COMPONENT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43893 STAR TOTAL ANKLE REPLACEMENT STAR SLIDING CORE NTG WALDEMAR LINK GMBH & CO 400-264 100305/0256

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention