BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 2003209 · Received February 16, 2011

    Report

    Report Number
    3003640913-2011-00003
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 16, 2011
    Manufacturer
    WALDEMAR LINK, GMBH & CO.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGES SENT SHOWED EXTREME WEAR AND FRACTURE MEDIAL TO LATERAL. CAUSE OF WEAR COULD NOT BE DETERMINED. REVIEW OF MFG RECORD SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    PT HAD THE STAR ANKLE POLY CORE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAR TOTAL ANKLE REPLACEMENT STAR SLIDING CORE NTG WALDEMAR LINK, GMBH & CO. 400-144 8002440

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention