BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP

    MDR report key: 1650057 · Received March 30, 2010

    Report

    Report Number
    1226188-2010-00005
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 2, 2010
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MECHANICAL TESTS WERE PERFORMED ON SIMILAR DEVICES.

    Description of Event or Problem · 1

    REVISION OF AN APEX STEM WHICH FAILED AT THE NECK/BODY TAPER. INITIAL SURGERY WAS CARRIED OUT ON (B) (6) 2002. STEM WAS 4 BY 11.5, SHORT, 47.5 NECK AND A 28 MINUS 3.5 HEAD. REVISION WAS CARRIED OUT ON (B) (6) 2010. THERE WERE NO COMPLICATIONS DURING SURGERY AND THE PATIENT IS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention