BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR FEMORAL STEM

    MDR report key: 3820036 · Received May 14, 2014

    Report

    Report Number
    1822565-2014-00610
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    February 27, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    KWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 TO ADDRESS A BROKEN FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288916 ZMR FEMORAL STEM KWZ ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention