BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3948949 · Received June 20, 2014

    Report

    Report Number
    3003640913-2014-00046
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-140 LOT 0913039. ALL RELEASED PARTS WERE WITHIN SPECIFICATION. THE COMPANY'S SURGERY REPORT FORM INDICATES THERE WAS SLIGHT WEAR ON THE SLIDING CORE MOBILE BEARING.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING WAS EXCHANGED DUE TO PAIN ASSOCIATED WITH IMPLANT WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363091 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 400-140 0913039

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention