BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML SM STATURE 15.0MM

    MDR report key: 2011394 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-03507
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K012364
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 REVISED FOR LOOSE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML SM STATURE 15.0MM 87 LPH, JDI LPH DEPUY ORTHOPAEDICS, INC. NA B68AP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention