BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3948928 · Received June 20, 2014

    Report

    Report Number
    3003640913-2014-00047
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING. MODEL # 99-028/12, LOT #: 1311182, EXPIRATION DATE: 04/01/2015, DEVICE MANUFACTURER DATE: 03/01/2010. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 99-0028/12, LOT NO, 1311182 OR PART NO. 400-256, LOT NO. 130418/1601. ALL RELEASED PARTS WERE WITHIN SPECIFICATION. THE COMPANY'S SURGERY REPORT FORM STATES THERE WAS NO FAILURE INVOLVED WITH THE IMPLANT COMPONENTS.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT WAS EXCHANGED DUE TO TALUS SUBSIDENCE. THE SLIDING CORE MOBILE BEARING WAS ALSO EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363090 STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-256 130418/1601

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention