BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2831665 · Received November 9, 2012

    Report

    Report Number
    1822565-2012-02311
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 ARTICULAR SURFACE WAS LOOSE IN THE TIBIAL PLATE AND WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61480696

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention