BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4425379 · Received January 15, 2015

    Report

    Report Number
    3003640913-2015-00001
    Event Type
    Injury
    Date Received
    January 15, 2015
    Date of Event
    January 5, 2015
    Report Date
    January 5, 2015
    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

    THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART # (B)(4), LOT # 8002450. ALL RELEASED PARTS WERE WITHIN SPECIFICATIONS. VISUAL EXAMINATION CONFIRMS THE POLY IS BROKEN AFTER 13.67 YEARS OF IMPLANTATION.

    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
    35630 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 400-140 8002450

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention