BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4316547 · Received December 4, 2014

    Report

    Report Number
    3003640913-2014-00091
    Event Type
    Injury
    Date Received
    December 4, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 20, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION CONFIRMS THAT THE DEGRADATION OF THE SLIDING CORE MOBILE BEARING IS CONSISTENT WITH MALALIGNMENT. THE PATIENT'S INCREASED WEIGHT IS CONTRIBUTING FACTOR TO THE DEGRADATION. THE DHR FOR PART NO. 99-0028/12, LOT NO 1007054 SHOWS NO DEVIATIONS. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE SLIDING CORE MOBILE BEARING WAS EXCHANGED DUE TO DEGRADATION OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782929 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 99-0028/12 1007054

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention