BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFLEX M-HA HIP STEM

    MDR report key: 411449 · Received August 8, 2002

    Report

    Report Number
    2243265-2002-00084
    Event Type
    Injury
    Date Received
    August 8, 2002
    Report Date
    July 22, 2002
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    MEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO BONE TISSUE NOT PROPERLY BONDING OR ADHERING TO COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFLEX M-HA HIP STEM IMPLANT MEH HOWMEDICA OSTEONICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention