BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 4112606 · Received September 10, 2014

    Report

    Report Number
    1822565-2014-01106
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 14, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE PATIENT WAS REVISED DUE TO INSTABILITY. A THICKER ARTICULAR SURFACE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559525 NEXGEN LPS-FLEX ARTICULAR SURFACE MBH MBH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention