BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 1131703 · Received August 11, 2008

    Report

    Report Number
    1226188-2008-00023
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    July 3, 2008
    Report Date
    August 7, 2008
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWY
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR REVISION OF RIGHT TOTAL HIP SECONDARY TO PAIN & INFECTION WITH STAPH AUREUS. DURING REVISION SURGERY, IT WAS NOTED BY THE SURGEON THAT: "IT APPEARED THAT THE INFECTION HAD STARTED BEHIND THE CUP."

    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 4 X 13MM 1253

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R EXP. 5/30/2011| HEAD 32MM, MFG. 5/26/06, LOT 1411| NECK, LONG 50, MFG 10/30/2006, LOT 1708| EXP. 10/30/2011