BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML MMA 10.5MM 6.3 IN STEM

    MDR report key: 371655 · Received January 16, 2002

    Report

    Report Number
    1818910-2002-00030
    Event Type
    Injury
    Date Received
    January 16, 2002
    Date of Event
    December 18, 2001
    Report Date
    January 16, 2002
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO A FRACTURE OF THE STEM AT THE JUNCTION OF THE TRIANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML MMA 10.5MM 6.3 IN STEM TOTAL HIP PROSTHESIS LPH DEPUY ORTHOPAEDICS, INC. NA 669110

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention