BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 3063431 · Received April 12, 2013

    Report

    Report Number
    1822565-2013-00642
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    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 IS REPORTED THAT THE ARTICULAR SURFACE WOULD NOT INSERT INTO THE TIBIAL BASE PLATE. ANOTHER ARTICULAR SURFACE WAS OPENED AND INSERTED WITHOUT A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158243 NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE JWH ZIMMER, INC. 62199135

    Patients

    Seq Age Sex Outcome Treatment
    1