BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE

    MDR report key: 1821495 · Received August 25, 2010

    Report

    Report Number
    1822565-2010-00620
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    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 THE PATIENT WAS REVISED DUE TO A FRACTURE OF THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 60823946

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention