BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN MODULAR SPIKE ARM POST

    MDR report key: 2093262 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01099
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE COATING ON THE INSTRUMENT IS FLAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MODULAR SPIKE ARM POST LXH ZIMMER INC 61634588

    Patients

    Seq Age Sex Outcome Treatment
    1