BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE GII FEMOR

    MDR report key: 2142344 · Received June 28, 2011

    Report

    Report Number
    1020279-2011-00225
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 28, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    IQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF SHOP ORDER PAPERWORK SHOWS NO ISSUES. DIMENSIONAL INVESTIGATION DID NOT DETERMINE ANY CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE STATED FAILURE MODE. ENGINEERING INVESTIGATION DETERMINED THAT A SLIGHT ANTERIOR OSTEOPHYTE MAY HAVE NOT BEEN ACCOUNTED FOR DURING SEGMENTATION. THIS WOULD HAVE PUSHED THE BLOCK UP AND CAUSED PINHOLES TO BE MORE ANTERIOR. THIS WOULD IN TURN CAUSE POSTERIOR AND DISTAL RESECTIONS TO BE LARGER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUTTING BLOCKS CAUSED A LARGER THAN DESIRED RESECTIONING OF THE BONE. DUE TO THIS, SURGERY TIME WAS EXTENDED BETWEEN 30 AND 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONAIRE GII FEMOR VISIONAIRE DSTL FEM CUTTING BLOCK - GII IQO SMITH & NEPHEW, INC. PM027513V1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR