BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS COMPLETE FEM CEM L LG

    MDR report key: 793826 · Received November 30, 2006

    Report

    Report Number
    1818910-2006-03745
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Date of Event
    September 5, 2006
    Report Date
    November 1, 2006
    Manufacturer
    DEPUY ORTHOPAEDICS, LTD.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    IMPLANTATION OF A LEFT FEMUR INTO A RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE FEM CEM L LG TOTAL KNEE REPLACEMENT JWH DEPUY ORTHOPAEDICS, LTD. NA 2027886

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR