BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 2141575 · Received June 16, 2011

    Report

    Report Number
    3003640913-2011-00012
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 5, 2011
    Report Date
    June 9, 2011
    Manufacturer
    WALDEMAR LINK, GMBH & CO.
    Product Code
    HSN
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POLY CORE RETURNED FOR EVAL. EVALUATION CONFIRMED WEAR WHICH IS NORMAL FOR 11 YEARS OF USE. REVIEW OF MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    POLY CORE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAR TOTAL ANKLE REPLACEMENT ANKLE PROTHESIS HSN WALDEMAR LINK, GMBH & CO. 400-142 0338198

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DELTOID RELEASE