BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP

    MDR report key: 1695767 · Received May 18, 2010

    Report

    Report Number
    1226188-2010-00009
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 5, 2010
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MECHANICAL TESTS WERE PERFORMED ON SIMILAR DEVICES.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON THE RIGHT HIP FOR A BROKEN STEM. MOST PROBABLE CAUSE IS THE STEM/PIN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP HIP STEM COMPONENT OF THA LPH OMNI LIFE SCIENCE, INC. 307

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention