BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2053464 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00473
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 SURGEON WAS UNABLE TO ASSEMBLE THE ARTICULAR SURFACE TO THE TIBIAL PLATE. A DELAY OF THIRTY MINS WAS INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61486214

    Patients

    Seq Age Sex Outcome Treatment
    1