BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP SYSTEM

    MDR report key: 2459852 · Received February 13, 2012

    Report

    Report Number
    1226188-2012-00012
    Event Type
    Injury
    Date Received
    February 13, 2012
    Report Date
    January 11, 2012
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT ONE OF HIS PTS FROM 2001 CAME INTO THE HOSPITAL EMERGENCY ROOM WITH A SMALL PIN FAILURE. THE PT REFUSED TREATMENT AND WAS TRANSFERRED TO ANOTHER AREA HOSPITAL. THERE IS NO OTHER SPECIFIC INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED LPH OMNILIFE SCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention