BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN SPIKE ARM

    MDR report key: 3904432 · Received May 28, 2014

    Report

    Report Number
    1822565-2014-00671
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 PROXIMAL PIN BROKE DURING SURGERY AND WAS RETAINED IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315125 NEXGEN SPIKE ARM LXH ZIMMER, INC. 61749955

    Patients

    Seq Age Sex Outcome Treatment
    1