BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX ARC HIP STEM

    MDR report key: 1974316 · Received January 20, 2011

    Report

    Report Number
    1226188-2011-00001
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 29, 2010
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    LZO
    PMA / PMN Number
    K090845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON BELIEVES THE PT WAS NON-COMPLIANT AND THAT THE FRACTURED FEMUR IS PROBABLY THE RESULT OF SOME TRAUMA. X-RAY IMAGE OF THE FRACTURED FEMUR WAS PROVIDED TO OMNILIFE SCIENCE.

    Description of Event or Problem · 1

    ORIGINAL SURGERY WAS CARRIED OUT ON (B)(6) 2010. THE PT CAME INTO THE ER AT (B)(6) ON (B)(6)2010. THE PT'S KNEE WAS SWOLLEN, BUT THE PT STATED THAT SHE DID NOT FALL. ACCORDING TO THE PT, THE EVENT TOOK PLACE WHEN SHE WENT TO SIT ON THE TOILET WITHOUT A HIP SEAT AND HEARD A "CRUNCH". SURGEON BELIEVES THE PT WAS NON-COMPLIANT AND THAT THIS IS PROBABLY THE RESULT OF SOME TRAUMA. REVISION SURGERY WAS COMPLETED ON (B)(6) 2010 WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX ARC HIP STEM HIP STEM LZO OMNLIFE SCIENCE, INC. 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention