BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS TAPERED FEMORAL STEM

    MDR report key: 3251830 · Received July 18, 2013

    Report

    Report Number
    3009701876-2013-00011
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 18, 2013
    Manufacturer
    PIPELINE ORTHOPEDICS LLC
    Product Code
    LPH
    PMA / PMN Number
    K112802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT DETERMINED TO HAVE CALCAR FRACTURE AFTER COMPLAINING OF BLISTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335413 RESTORIS TAPERED FEMORAL STEM LPH PIPELINE ORTHOPEDICS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention