BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN STEMMED TIBIAL BROACH IMPACTOR

    MDR report key: 3802440 · Received February 21, 2014

    Report

    Report Number
    1822565-2014-00210
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 23, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 PEG ON THE TIBIAL IMPACTOR CAME OFF DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110008 NEXGEN STEMMED TIBIAL BROACH IMPACTOR LXH ZIMMER, INC. 60582612

    Patients

    Seq Age Sex Outcome Treatment
    1