BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFLEX MHA STEM

    MDR report key: 1564191 · Received December 21, 2009

    Report

    Report Number
    2249697-2009-00920
    Event Type
    Injury
    Date Received
    December 21, 2009
    Date of Event
    December 1, 2009
    Report Date
    December 1, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROCESS. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    OMNIFLEX STEM REVISION PERFORMED DUE TO THE GRADE 3A OSTEOLYSIS WHICH WAS CAUSED BY POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFLEX MHA STEM IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention