BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE GII FEMOR

    MDR report key: 2161345 · Received July 13, 2011

    Report

    Report Number
    1020279-2011-00251
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 27, 2011
    Report Date
    July 12, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGICAL TEAM EXPERIENCED DIFFICULTY WITH THE BLOCKS FITTING PROPERLY CAUSING AN EXTENSION OF SURGERY TIME BETWEEN 31-60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONAIRE GII FEMOR VISIONAIRE LT CUTTING BLOCK KIT-GII JWH SMITH & NEPHEW, INC. PM024767

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization