BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4253019 · Received November 13, 2014

    Report

    Report Number
    3003640913-2014-00087
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 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

    ADDITIONAL REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING. MODEL#: 400-141. LOT #: 1010032. EXPIRATION DATE: 12/01/2016. DEVICE MANUFACTURER DATE: 12/01/2011. VISUAL EXAMINATION OF EXPLANTS SHOW INSIGNIFICANT WEAR. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-141, LOT NO. 1010032. THE DHR FOR PART NO. 400-254, LOT NO. 110505/1564. (B)(4). ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT WAS EXCHANGED TO CORRECT POSITIONING. THE SLIDING CORE MOBILE BEARING WAS ALSO EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733730 STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-254 110505/1564

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention