BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZMR HIP SYSTEM FEMORAL STEM

    MDR report key: 4027615 · Received August 5, 2014

    Report

    Report Number
    1822565-2014-00945
    Event Type
    Death
    Date Received
    August 5, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    KWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO A FRACTURED STEM. THE PT DIED AFTER THE REVISION SURGERY, REPORTEDLY THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458406 ZMR HIP SYSTEM FEMORAL STEM KWZ ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death CATALOG #00999301745, LOT # UNK| ZMR HIP SYSTEM FEMORAL BODY,