BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3113568 · Received May 2, 2013

    Report

    Report Number
    3003640913-2013-00018
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    WALDEMAR LINK, GMBH & CO
    Product Code
    HSN
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SLIDING CORE BEARING REVISED AFTER 9 YEARS OF IMPLANTATION. PT HAD CYSTS ON BOTH THE TIBIA AND THE TALAR. REVIEW OF DEVICE HISTORY RECORDS SHOWS NO ANOMALIES.

    Description of Event or Problem · 1

    PT HAD STAR SLIDING CORE BEARING REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191002 STAR TOTAL ANKLE REPLACEMENT STAR SLINDING THE CORE HSN WALDEMAR LINK, GMBH & CO 400-141 0340011

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention