BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4004667 · Received July 24, 2014

    Report

    Report Number
    3003640913-2014-00054
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING, MODEL #400-141, LOT: 0921074, EXP DATE: 03/01/2015. DEVICE MFR DATE: 03/01/2010. ADDITIONAL REMOVED COMPONENTS: TIBIAL COMPONENT, MODEL # 400-264, LOT# 090807/1951, EXP DATE: 10/01/2014, DEVICE MFR DATE: 10/01/2009. THERE WERE NO DEVIATIONS REPORTED IN THE DHRS FOR PART NO. 400-141, LOT NO. 0921074. THE DHR FOR PART NO. 400-258, LOT NO. 090319/2607 NOTES THAT 5 OUT OF THE 30 PIECES WERE SCRAPPED, AND PART NO. 400-264, LOT NO. 090807/1951 NOTES THAT 5 OUT OF 30 PIECES WERE ALSO SCRAPPED. ALL RELEASED PARTS WERE WITHIN SPECIFICATION. THE TALAR AND TIBIAL COMPONENTS WERE NOT RETURNED, ONLY THE SLIDING CORE MOBILE BEARING IS AVAILABLE. VISUAL EXAMINATION OF THE SLIDER CORE CONFIRMS WEAR MARKS CONSISTENT WITH THE MALALIGNMENT OF COMPONENTS.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SYSTEM WERE REVISED TO FUSION DUE TO MALALIGNMENT AND TALAR SUBSIDENCE CAUSED BY POOR BONE QUALITY BENEATH THE TALAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435417 STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-258 090319/2607

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention