BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3676812 · Received February 27, 2014

    Report

    Report Number
    3003640913-2014-00020
    Event Type
    Injury
    Date Received
    February 27, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 7, 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

    THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NUMBERS 400-142 LOT 0912074. ALL RELEASED PARTS WERE WITHIN SPECIFICATION. VISUAL EXAMINATION DENOTES WEAR ASSOCIATED WITH IMPLANT RUBBING AGAINST THE BONE, AND A FEW MARKS CONSISTENT WITH REMOVAL.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING WAS EXCHANGED DUE TO IMPLANT WEAR AND COMPONENT'S X-RAY WIRE BEING EXPOSED. COMPANY REPORT FORM INDICATES EXCESS BONE GROWTH CAUSED MOVEMENT OF X-RAY WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121094 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 400-142 0912074

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention