BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX ARC HIP STEM

    MDR report key: 2896502 · Received December 28, 2012

    Report

    Report Number
    1226188-2012-00083
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    LZO
    PMA / PMN Number
    K090845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON (B)(6) 2012 FOR A LOOSE ARC STEM. ORIGINAL SURGERY PERFORMED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX ARC HIP STEM APEX ARC STEM, SIZE 3 LZO OMNLIFE SCIENCE, INC. 8604

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R