BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS PFJ TROCHLEAR COM SM+ RT

    MDR report key: 1061365 · Received June 13, 2008

    Report

    Report Number
    1818910-2008-02533
    Event Type
    Injury
    Date Received
    June 13, 2008
    Report Date
    May 16, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/R47
    Removal / Correction Number
    NA
    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

    A REPORT REC'D FROM ANOTHER COUNTRY'S DEVICE REGISTRY ALLEGES REVISION FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS PFJ TROCHLEAR COM SM+ RT 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention