BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXTEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 3213815 · Received July 3, 2013

    Report

    Report Number
    1822565-2013-01070
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WAS REPORTED THAT THE PT'S KNEE WAS REVISED DUE TO LOOSENING OF THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303648 NEXTEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61552040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention