BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3313232 · Received August 22, 2013

    Report

    Report Number
    3003640913-2013-00039
    Event Type
    Injury
    Date Received
    August 22, 2013
    Date of Event
    July 26, 2013
    Report Date
    August 23, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVISED COMPONENT: STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT, MODEL #: 400-263, LOT #: 10114/0707, DEVICE MFR DATE: 03/2010, EXP: 03/01/2015. STAR TOTAL ANKLE REPLACEMENT SLIDING CORE, MODEL #: 99-0028/13, LOT #: 0907132, DEVICE MFR DATE: 10/2009, EXP DATE: 10/01/2014. STAR TOTAL ANKLE REPLACEMENT SYSTEM REVISED TO FUSION AFTER 1.5 YEARS OF IMPLANTATION. VISUAL EVAL CONFIRMED COMPONENTS WERE INTACT. DEVICE HISTORY RECORD SHOWS NO ANOMALIES.

    Description of Event or Problem · 1

    PT HAD STAR TOTAL ANKLE REPLACEMENT SYSTEM REVISED TO FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409468 STAR TOTAL ANKLE REPLACEMENT STAR SLIDING CORE NTG SMALL BONE INNOVATIONS, INC. 400-255 091002/2079

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention