BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARC STEM

    MDR report key: 2839530 · Received November 14, 2012

    Report

    Report Number
    1226188-2012-00070
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 14, 2012
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    LZO
    PMA / PMN Number
    K090845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THA REVISED FOR DISLOCATION. ACETABULAR CUP WAS REVISED FOR POSITION. ARC MODULAR NECK WAS EXPLANTED AND REPLACED BY A NEW NECK. ORIGINAL DATE OF SURGERY IS (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARC STEM NONE LZO OMNLIFE SCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention