BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 1055656 · Received May 20, 2008

    Report

    Report Number
    1226188-2008-00006
    Event Type
    Injury
    Date Received
    May 20, 2008
    Date of Event
    January 9, 2008
    Report Date
    May 12, 2008
    Manufacturer
    OMNI LIFE SCIENCE
    Product Code
    KWY
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL INCIDENT UNKNOWN BY MFR. HOSPITAL MEDWATCH FORM SENT TO OMNI PREVIOUS ADDRESS. HOSPITAL MEDWATCH FORM ATTACHED.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED FOR REVISION OF RIGHT HIP, SECONDARY TO PAIN AND INSTABILITY, FROM BROKEN COMPONENTS. IT WAS REPORTED THAT PT WAS SATISFACTORY POST OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM KWY OMNI LIFE SCIENCE 121456 502

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention