BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP

    MDR report key: 1592724 · Received January 26, 2010

    Report

    Report Number
    1226188-2010-00001
    Event Type
    Injury
    Date Received
    January 26, 2010
    Date of Event
    December 30, 2009
    Report Date
    December 31, 2009
    Manufacturer
    OMNI LIFE SCIENCE, INC
    Product Code
    LPH
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MECHANICAL TESTS WERE PERFORMED ON SIMILAR DEVICES.

    Description of Event or Problem · 1

    PATIENT UNDERWENT HIP REVISION SURGERY DUE TO MODULAR STEM/PIN FAILURE. REVISION WAS CARRIED OUT ON (B) (6) 2010. DATE OF ORIGINAL IMPLANT - (B) (6) 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP FEMORAL COMPONENT OF THA LPH OMNI LIFE SCIENCE, INC 121759 196

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention