BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 3904434 · Received May 28, 2014

    Report

    Report Number
    2648920-2014-00138
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ZIMMER
    Product Code
    MBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE 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 THE SURGEON COULDN'T INSERT THE ARTICULAR SURFACE PROPERLY SO HE COMPLETED THE SURGERY WITH ANOTHER SURFACE OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315057 NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE MBH ZIMMER 62561943

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR