BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR FEMORAL STEM

    MDR report key: 2802580 · Received October 19, 2012

    Report

    Report Number
    1822565-2012-02150
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 WHEN THE STEM WAS OPENED, THE SCREW WAS NOT IN THE BOX. A NEW IMPLANT WAS OPENED AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR FEMORAL STEM LPH ZIMMER, INC. 61951081

    Patients

    Seq Age Sex Outcome Treatment
    1