BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2092626 · Received May 10, 2011

    Report

    Report Number
    1822565-2011-01134
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 AFTER A FALL DUE TO DISLOCATION OF IPSILATERAL HIP. SURGEON REMARKED THAT TIBIA WAS IN EXTERNAL ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 60110210

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention