BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2860621 · Received December 5, 2012

    Report

    Report Number
    1822565-2012-02466
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    August 29, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 WAS REPORTED THAT THE ARTICULAR SURFACE WAS UNABLE TO BE SEATED. ANOTHER COMPONENT OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 62069767

    Patients

    Seq Age Sex Outcome Treatment
    1