BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS M BRDG BRG STD+/LG 10.0

    MDR report key: 1822509 · Received August 27, 2010

    Report

    Report Number
    1818910-2010-05984
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS GROSS POLY WEAR. THE KNEE SUSTAINED IRREVERSIBLE DAMAGE TO THE METAL COMPONENTS REQUIRING A TOTAL REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS M BRDG BRG STD+/LG 10.0 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA SD80X1018

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention