BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN ROTATING HINGE ARTICULAR SURFACE

    MDR report key: 3162165 · Received June 6, 2013

    Report

    Report Number
    1822565-2013-00922
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 LOCKING SCREW WOULD NOT ENGAGE TO KEEP THE ARTICULAR SURFACE IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251129 NEXGEN ROTATING HINGE ARTICULAR SURFACE KRO ZIMMER, INC. 61794252

    Patients

    Seq Age Sex Outcome Treatment
    1