BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE M/B PAT POR STD+

    MDR report key: 2113186 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08219
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    P830055/S113
    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

    OSTEOLYSIS NOTED ON X-RAY. THE LEFT KNEE WAS REVISED, SCRATCHES WERE NOTED ON FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE M/B PAT POR STD+ 87 NJL NJL DEPUY (IRELAND) NA 2441038

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention