BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 3243224 · Received July 19, 2013

    Report

    Report Number
    3007963827-2013-00022
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO 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 WHEN THE DEVICE WAS REMOVED FROM THE BOX, THE FIRST STERILE SEAL WAS LOOSE AND NOT ATTACHED TO THE PLASTIC PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338292 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER 61971131

    Patients

    Seq Age Sex Outcome Treatment
    1