BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 907702 · Received September 4, 2007

    Report

    Report Number
    1226188-2007-00009
    Event Type
    Injury
    Date Received
    September 4, 2007
    Date of Event
    August 14, 2007
    Report Date
    August 28, 2007
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWY
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG NUMBER 220210 APEX MODULAR SHORT 40 NECK, CATALOG NUMBER 332800 ALUMINA HEAD 28MM MEDIUM (+0). DEVICE HISTORY RECORDS FOR THE STEM ARE INTACT AND CONFORMING AND INDICATE MANUFACTURED TO SPECIFICATION. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    POROUS FEMORAL STEM REVISED 51 MONTHS AFTER PRIMARY TOTAL HIP ARTHROPLASTY. DURING REVISION SURGEON NOTED FAILURE OF THE FEMORAL STEM ALIGNMENT PIN. PT IN GOOD CONDITION POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM KWY OMNI LIFE SCIENCE, INC. 3 X 11.5 STEM 403

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention