BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4024278 · Received August 13, 2014

    Report

    Report Number
    3003640913-2014-00058
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 31, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING. MODEL#: 99-0028/14; LOT#:1009078; EXPIRATION DATE: 05/01/2018; DEVICE MANUFACTURE DATE: 05/01/2013; THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-263, LOT NO 130314/0106, OR PART NO. 99-0028/14, LOT NO. 1009078. ALL RELEASED PARTS WERE WITHIN SPEC. VISUAL EXAMINATION CONFIRMS MARKS CONSISTENT WITH REMOVAL OF DEVICE AND SHOW INSIGNIFICANT WEAR. PREVIOUS REVISION SURGERY (MDR 3006340913-2013-00059) PERFORMED AS TEMPORARY SOLUTION. SURGEON ORDERED THE CUSTOM IMPLANT AT TIME OF FIRST REVISION KNOWING THIS SECOND REVISION WOULD MOST LIKELY BE REQUIRED.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT AND SLIDING CORE MOBILE BEARING WAS EXCHANGED TO PROVIDE THE PT WITH A CUSTOM IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483394 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-263 130314/0106

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention