BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4253020 · Received November 13, 2014

    Report

    Report Number
    3003640913-2014-00088
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    October 31, 2014
    Report Date
    October 31, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPORT FORM STATES THAT SURGEON PERFORMED A BROSTROM PROCEDURE DURING REVISION SURGERY, WHICH INDICATES THE PATIENT HAD VARUS INSTABILITY. LATERAL LIGAMENT LAXITY MAY HAVE CONTRIBUTED TO THE FRACTURED IMPLANT. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 99-0028/11, LOT NO. 0908026. 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
    732309 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 99-0028/11 0908026

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention