BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 1282291 · Received December 29, 2008

    Report

    Report Number
    1226188-2008-00038
    Event Type
    Malfunction
    Date Received
    December 29, 2008
    Date of Event
    November 25, 2008
    Report Date
    December 24, 2008
    Manufacturer
    OMN LIFE SCIENCE, INC.
    Product Code
    KWY
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER OPERATIVE REPORT, "PATIENT WAS ON GOLF COURSE AND MOVED SWIFTLY AND QUICKLY FELT SOMETHING SHIFT AND HAD PAIN. HIS IMPLANT WAS NOT DISLOCATED BUT IT WAS BELIEVED TO BE FAILED." REVISION LEFT TOTAL HIP ARTHROPLASTY CONDUCTED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM KWY OMN LIFE SCIENCE, INC. SZ5 X13MM 426

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R NECK| EXP. 11/30/2008