BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 1193292 · Received October 7, 2008

    Report

    Report Number
    1226188-2008-00031
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 6, 2008
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWY
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: REVISION SURGERY DUE TO INFECTION, NOT IMPLANT FAILURE. ADD'L IMPLANT EXPLANTED: NECK, SHORT 35, LOT# 788, CAT#230205, MFG 2/12/05, EXP 2/28/10.

    Description of Event or Problem · 1

    LEFT TOTAL HIP PERFORMED DUE TO INFECTION 40 MONTHS AFTER ORIGINAL SURGERY. IT WAS STATED THAT THE OMNI STEM AND NECK WERE REMOVED INTACT AND THE SURGERY WENT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM KWY OMNI LIFE SCIENCE, INC. SZ 3X11.5MM 749

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R