BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR PROLONG ARTICULAR SURFACE

    MDR report key: 2133532 · Received June 15, 2011

    Report

    Report Number
    1822565-2011-01408
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    August 1, 2008
    Report Date
    May 19, 2011
    Manufacturer
    ZIMMER INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 PT WAS REVISED DUE TO THE ARTICULAR SURFACE FRACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR PROLONG ARTICULAR SURFACE JWH ZIMMER INC. 60635039

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention