BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM CEM L STD

    MDR report key: 1040455 · Received May 8, 2008

    Report

    Report Number
    1818910-2008-01432
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    DEPUY - CORK, A DIV OF DEPUY ORTHOPAEDICS INC
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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

    PT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AT THE IMPLANT CEMENT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE FEM CEM L STD 87NJL NJL DEPUY - CORK, A DIV OF DEPUY ORTHOPAEDICS INC NA 2338037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention