BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3948945 · Received June 20, 2014

    Report

    Report Number
    3003640913-2014-00049
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NUMBER 400-142, LOT NUMBER A/26229. ALL RELEASED PARTS WERE WITHIN SPECIFICATION. VISUAL EXAMINATION CONFIRMS THE SLIDING CORE MOBILE BEARING WAS FRACTURED. THIS FRACTURE OCCURRED AFTER 10.5 YEARS OF IMPLANTATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363177 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 400-142 A/26229

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention