BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD 10MM

    MDR report key: 1250688 · Received December 2, 2008

    Report

    Report Number
    1818910-2008-05686
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    October 2, 2008
    Report Date
    November 3, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    PMA074
    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 COMP RP INSERT STD 10MM 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA A86CG4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention