BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR FEMORAL STEM

    MDR report key: 3820016 · Received May 14, 2014

    Report

    Report Number
    1822565-2014-00623
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    KWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PAIN AND A BROKEN STEM. THE STEM REQUIRED TREPHINES IN ORDER TO REMOVE THE STEM FROM THE CANAL; HOWEVER, THE SURGEON WAS UNABLE TO REMOVE THE IMPLANT FROM THE TREPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289061 ZMR FEMORAL STEM KWZ ZIMMER INC 53379500

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention CATALOG #00999001946, LOT #60013015| ZMR FEMORAL BODY SPOUT,