BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4076389 · Received September 2, 2014

    Report

    Report Number
    3003640913-2014-00062
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 11, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT FRACTURE OCCURRED AFTER 13 YEARS OF IMPLANTATION. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-140, LOT NO. 0042074. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING WAS EXCHANGED DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532102 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 400-140 0042074

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention