BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR FEMORAL STEM

    MDR report key: 4112595 · Received September 10, 2014

    Report

    Report Number
    1822565-2014-01103
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 THE PATIENT WAS REVISED DUE TO A STEM FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559788 ZMR FEMORAL STEM KWZ KWZ ZIMMER, INC. 76998000R

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention ZMR HIP SYSTEM FEMORAL BODY REVISION NITRIDED:| CATALOG #00999601745, LOT #60786455