BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS 3PEG MOD ROT PAT CEM SM

    MDR report key: 1040470 · Received May 8, 2008

    Report

    Report Number
    1818910-2008-01659
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 10, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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 A DISASSOCIATED PATELLA. SHE REPORTS THAT, IN 2008, SHE SAT UP, GOT UP, AND THE PATELLA BROKE IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS 3PEG MOD ROT PAT CEM SM 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA A54CKA000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention