BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K1 MONOBLOCK PRESS-FIT HIP STEM

    MDR report key: 1650059 · Received March 30, 2010

    Report

    Report Number
    1226188-2010-00004
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 4, 2010
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K060072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON IMPROPERLY TRIALED THE STEM.

    Description of Event or Problem · 1

    DELAY IN SURGERY BY 2.5 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K1 MONOBLOCK PRESS-FIT HIP STEM HIP PROSTHESIS, UNCEMENTED LPH OMNI LIFE SCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention