BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE GII FEMOR

    MDR report key: 2070946 · Received April 27, 2011

    Report

    Report Number
    1020279-2011-00143
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 27, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SHOP ORDER PAPERWORK SHOWS NO ISSUES. PARTS WERE NOT RETURNED, THEREFORE, NO DIMENSIONAL INVESTIGATION COULD BE COMPLETED. ENGINEERING INVESTIGATION DETERMINED DISTAL FEMUR RESECTION WAS MADE AGGRESSIVE BY 0.5MM. THE PRE-ALIGNMENT WAS PLANNED FOR IMPLANT THICKNESS BUT THE DISTAL RESECTION DID NOT RESECT TO THE SULCUS. POSTERIOR RESECTION WAS +1MM OVER IMPLANT THICKNESS, PROXIMAL RESECTION WAS MADE AGGRESSIVE BY 0.5MM. THE RESECTION WAS SET FOR A 9MM INSERT. MEDIAL CONDYLE RESECTION ON THE TIBIA SHOULD HAVE OCCURRED BASED ON THE PRE-ALIGNMENT. ALSO, TIBIAL ALIGNMENT SEEMS TO BE ACCEPTABLE. OUR INVESTIGATION COULD NOT DETERMINE A SPECIFIC CAUSE OF THE FAILURE STATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON EXPERIENCED PROBLEMS WITH THE BLOCK FITTING PROPERLY WHICH EXTENDED SURGERY TIME 30-60 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. PM024584V1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization