BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 4780528 · Received May 18, 2015

    Report

    Report Number
    1822565-2015-00722
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 16, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 IS REPORTED THAT SURGEON IMPLANTED AND THEN REMOVED THE ARTICULAR SURFACE. IT WAS THEN NOTED THAT A DEFECT WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322630 NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE MBH ZIMMER, INC. 61490144

    Patients

    Seq Age Sex Outcome Treatment
    1