BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS 3PEG MOD ROT PAT CEM SM+

    MDR report key: 1060572 · Received June 12, 2008

    Report

    Report Number
    1818910-2008-02142
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    February 18, 2008
    Report Date
    May 15, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MBH
    PMA / PMN Number
    P830055/S34
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    PATELLA WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS 3PEG MOD ROT PAT CEM SM+ 87MBH MBH DEPUY ORTHOPAEDICS, INC. NA W85BJ1006

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention