BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN STEM EXTENSION, OFFSET

    MDR report key: 2182616 · Received July 5, 2011

    Report

    Report Number
    1822565-2011-01592
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 WAS REPORTED THAT WHEN AN OFFSET STEM WAS OPENED FOR USE, THE SCREW WAS MISSING. ANOTHER SCREW WAS AVAILABLE FOR COMPLETION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEM EXTENSION, OFFSET JWH ZIMMER INC 61756218

    Patients

    Seq Age Sex Outcome Treatment
    1