BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML SM STATURE 13.5MM

    MDR report key: 1080904 · Received July 22, 2008

    Report

    Report Number
    1818910-2008-02880
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K012364
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    PATIENT WAS REVISED TO PROSTALAC TO ADDRESS INFECTION OF BI-POLAR AML HIP (RIGHT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML SM STATURE 13.5MM 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA CK3A71000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention