BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML MMA 10.5MM 6.3 IN STEM

    MDR report key: 482462 · Received September 9, 2003

    Report

    Report Number
    1818910-2003-00601
    Event Type
    Injury
    Date Received
    September 9, 2003
    Report Date
    August 13, 2003
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS REVISED DUE TO A FRACTURED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML MMA 10.5MM 6.3 IN STEM TOTAL HIP REPLACEMENT LPH DEPUY ORTHOPAEDICS, INC. NA 603380

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention