BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 1360906 · Received April 13, 2009

    Report

    Report Number
    1226188-2009-00004
    Event Type
    Injury
    Date Received
    April 13, 2009
    Date of Event
    October 29, 2008
    Report Date
    April 13, 2009
    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
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    FAILED APEX SURGICAL PROSTHESIS. SURGERY PERFORMED IN 2008, 76 MONTHS AFTER INITIAL THA. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM KWY OMNI LIFE SCIENCE, INC. 5 X 14.5MM 201

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL HEAD| ADD'L OMNI PRODS IMPLANTED DURING ORIGINAL SURGERY| NECK| EXP. 10/06| EXP. 02/2007