BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3522390 · Received November 15, 2013

    Report

    Report Number
    3003640913-2013-00051
    Event Type
    Injury
    Date Received
    November 15, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVISED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT, TALAR COMPONENT, MODEL#: 400-255, LOT#: 091204/1569, DEVICE MFR DATE: 05/2010, EXPIRATION DATE: 05/01/2015, DATE OF IMPLANTATION: (B)(6) 2012, DATE OF EXPLANTATION: (B)(6) 2013. STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE MOBILE BEARING, MODEL #: 400-142, LOT#: 0950058, DEVICE MFR DATE: 12/2010, EXPIRATION DATE: 12/01/2015, DATE OF IMPLANTATION: (B)(6) 2012, DATE OF EXPLANTATION: (B)(6) 2013. PATIENT'S NON-COMPLIANCE LEAD TO AN INFECTION RESULTING IN THE REMOVAL OF THE STAR TOTAL ANKLE REPLACEMENT SYSTEM.

    Description of Event or Problem · 1

    PATIENT HAD STAR TOTAL ANKLE REPLACEMENT SYSTEM REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593929 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-263 100114/0584

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention