BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3948944 · Received June 20, 2014

    Report

    Report Number
    3003640913-2014-00048
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 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: SLIDING CORE MOBILE BEARING, MODEL#: 400-140, LOT#: 0907143. EXPIRATION DATE: 04/01/2014. DEVICE MANUFACTURE DATE: 04/2009. ADDITIONAL REMOVED COMPONENTS: TIBIAL COMPONENT, MODEL#: 400-263, LOT#: 090618/3580. EXPIRATION DATE: 09/01/2014. DEVICE MANUFACTURE DATE: 09/2009. THERE WERE NO DEVIATIONS REPORTED IN THE DHRS FOR PART NO. 400-254 LOT NO. 030812/3729, PART NO. 400-263, LOT NO. 090618/3580, AND PART NO. 400-140 LOT, 0907143. ALL RELEASED PARTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SYSTEM WERE REVISED TO FUSION DUE TO OSTEOPOROSIS, TIBIAL SUBSIDENCE, COLLAPSED TALAR AND LACK OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363087 STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-254 030812/3729

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention