BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3850505 · Received May 20, 2014

    Report

    Report Number
    3003640913-2014-00036
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 17, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-140, LOT NO. 0942101. COMPANY REPORT FORM INDICATES PATIENT'S OVER ACTIVITY CONTRIBUTED TO THE IMPLANT WEAR.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING WAS EXCHANGED DUE TO IMPLANT WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299046 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 400-140 0942101

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention