BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ROTATING HINGE FEMORAL COMPONENT

    MDR report key: 2050849 · Received April 1, 2011

    Report

    Report Number
    1822565-2011-00831
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PT WAS REVISED DUE TO FRACTURE OF THE HINGE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN ROTATING HINGE FEMORAL COMPONENT KRO ZIMMER, INC. 60370497

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention POST EXTENSION, CATALOG #00588005017, LOT#41998600| NEXGEN ROTATING HINGE ARTICULAR SURFACE WITH HINGE