BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM CEM L STD

    MDR report key: 1250690 · Received December 2, 2008

    Report

    Report Number
    1818910-2008-05685
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    October 2, 2008
    Report Date
    November 3, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    NJL
    PMA / PMN Number
    P830055/R44
    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

    REVISION REQUIRED, QUERY INFECTION, OR THIRD PARTICLE WEAR. AT 12 MONTH POST OP PERIOD PATIENT COMPLAINING OF PAIN AND OSTEOLYSIS REVISION PERFORMED AND METALOSIS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE FEM CEM L STD 87NJL NJL DEPUY INTERNATIONAL, LTD NA 2160726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention