BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 1056174 · Received June 3, 2008

    Report

    Report Number
    1226188-2008-00013
    Event Type
    Injury
    Date Received
    June 3, 2008
    Date of Event
    May 7, 2008
    Report Date
    June 2, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICE: NECK, SHORT +47.5, CAT #220310, LOT# 304.

    Description of Event or Problem · 1

    TOTAL HIP REVISION SURGERY PERFORMED IN 2008, 76 MONTHS AFTER ORIGINAL THA. IT WAS STATED THAT THERE WAS NO COMPLICATIONS DURING THE REVISION 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 121455 268

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention