BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3720597 · Received March 24, 2014

    Report

    Report Number
    3003640913-2014-00028
    Event Type
    Injury
    Date Received
    March 24, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 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. STAR 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. COMPANY REPORT FORM STATES PATIENT WENT FROM (B)(6) POUNDS AT TIME OF PRIMARY TO (B)(6) AT TIME OF EXPLANTATION, AN THAT COMPONENTS WERE WELL FIXED TO THE BONE.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT WAS REMOVED TO CORRECT TALAR SUBLUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171913 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-264 091204-0097

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention