BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE M/B PAT POR STD+

    MDR report key: 2252957 · Received September 19, 2011

    Report

    Report Number
    1818910-2011-18454
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 4, 2011
    Manufacturer
    DEPUY IRELAND
    Product Code
    NJL
    PMA / PMN Number
    P830055/S113
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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

    REQUIRED REVISION DUE TO PAIN SUBSEQUENT TO PRIMARY TOTAL KNEE REPLACEMENT WITH LCS DUOFIX COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE M/B PAT POR STD+ KNEE NJL DEPUY IRELAND 2380368

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention