BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER OTJ METAL PROVISIONAL PROXIMAL BODY

    MDR report key: 2334975 · Received October 26, 2011

    Report

    Report Number
    1822565-2011-02357
    Event Type
    Malfunction
    Date Received
    October 26, 2011
    Date of Event
    September 30, 2011
    Report Date
    September 30, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    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 SURGEON COULD NOT REMOVE TRAIL FROM THE STEM. THE SURGEON HAD TO REAM UP A SIZE AND IMPLANT A LARGER STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER OTJ METAL PROVISIONAL PROXIMAL BODY LXH ZIMMER INC 61161833

    Patients

    Seq Age Sex Outcome Treatment
    1