BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS TAPERED FEMORAL STEM

    MDR report key: 3203726 · Received June 26, 2013

    Report

    Report Number
    3009701876-2013-00008
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 20, 2013
    Manufacturer
    PIPELINE ORTHOPEDICS LLC
    Product Code
    LPH
    PMA / PMN Number
    K112802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE PREPARING THE FEMUR FOR THE STEM IMPLANT, THE SURGEON NOTICED THAT THE FEMUR HAD FRACTURED. THE FRACTURE WAS CLOSED WITH CABLES AND THE STEM WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290275 RESTORIS TAPERED FEMORAL STEM LPH PIPELINE ORTHOPEDICS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention