BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN IMPLANT

    MDR report key: 4112856 · Received September 17, 2014

    Report

    Report Number
    1822565-2014-01143
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    August 19, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 PATIENT WAS REVISED DUE TO INJURY AND CONTINUES TO EXPERIENCE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577208 UNKNOWN NEXGEN IMPLANT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention