BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP

    MDR report key: 1635162 · Received March 16, 2010

    Report

    Report Number
    1226188-2010-00003
    Event Type
    Injury
    Date Received
    March 16, 2010
    Date of Event
    February 16, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MECHANICAL TESTS WERE PERFORMED ON SIMILAR DEVICES.

    Description of Event or Problem · 1

    REVISION SURGERY CARRIED OUT ON (B) (6) 2010. ORIGINAL IMPLANT SURGERY WAS CARRIED OUT ON (B) (6) 2003. THE SMALL PIN ON THE APEX MODULAR STEM WAS WORN DOWN BUT NOT COMPLETELY SHEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP FEMORAL COMPONENT OF THA LPH OMNI LIFE SCIENCE, INC. 121305B 377

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention