BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3676813 · Received February 27, 2014

    Report

    Report Number
    3003640913-2014-00022
    Event Type
    Injury
    Date Received
    February 27, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 11, 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

    ADD'L REMOVED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE MOBILE BEARING, MODEL #: 99-0028/11, LOT #: 0946072, EXPIRATION DATE: 12/01/2014, DATE OF IMPLANTATION: (B)(6) 2013, DATE OF EXPLANTATION: (B)(6) 2014, DEVICE MANUFACTURE DATE: 12/2009; START TOTAL ANKLE REPLACEMENT, TALAR COMPONENT, MODEL #: 400-252, LOT #: 091204/2311, EXPIRATION DATE: 05/01/2015, DATE OF IMPLANTATION: (B)(6) 2013, DATE OF EXPLANTATION: (B)(6) 2014, DEVICE MANUFACTURE DATE: 05/2010. THERE WERE NO DEVIATIONS REPORTED IN THE DHRS FOR ALL THE PARTS. VISUAL EXAMINATION CONFIRMED WEAR ON THE SLIDING CORE MOBILE BEARING CONSISTENT WITH THAT WHICH OCCURS WHEN THERE IS MEDIAL IMPINGEMENT. THE TIBIAL AND TALAR COMPONENTS SHOWED MARKS CONSISTENT WITH REMOVAL.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT WAS REMOVED DUR TO PAIN AND POSSIBLE INFECTION. AN ANTIBIOTIC SPACER WAS PLACED, AND COMPONENTS WILL BE REPLACED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120876 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-263 100114/0562

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention