BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ROTATING HINGE ARTICULAR SURFACE

    MDR report key: 1884554 · Received October 19, 2010

    Report

    Report Number
    1822565-2010-00950
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 11, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    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 PATIENT WAS REVISED DUE TO THE BREAKAGE OF THE HINGE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN ROTATING HINGE ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. NA 61007322

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention