BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS ARTICULAR SURFACE

    MDR report key: 1892220 · Received October 26, 2010

    Report

    Report Number
    1822565-2010-01013
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    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 FOR A BROKEN INSERT. PT TOLD SURGEON THAT IT HAPPENED WHEN HE WAS KNEELING DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 67437200

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention