BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML STD 15.0MM 6.3 IN STEM

    MDR report key: 1923869 · Received December 8, 2010

    Report

    Report Number
    1818910-2010-09408
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LZO
    PMA / PMN Number
    K941847
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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

    PT REVISED FOR LOOSE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML STD 15.0MM 6.3 IN STEM 87 LZO LZO DEPUY ORTHOPAEDICS, INC. NA R4RGR1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention