BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LEGACY LPS-FLEX ARTICULAR SURFACE

    MDR report key: 1993720 · Received January 13, 2011

    Report

    Report Number
    1822565-2011-00071
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON OPENING THE LAST LAYER OF STERILITY, THE SCRUB TECH NOTICED A SMEAR ON THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LEGACY LPS-FLEX ARTICULAR SURFACE KNEE PROSTHESIS MBH ZIMMER, INC. 61530040

    Patients

    Seq Age Sex Outcome Treatment
    1