BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE KNEE GUIDE - 42-422451

    MDR report key: 1992131 · Received February 15, 2011

    Report

    Report Number
    1825034-2011-00102
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K102795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. SUPPLIER'S EVALUATION OF EVENT WAS LIMITED TO REVIEW OF PLANNING AND PROCEDURES AS THE DEVICES WERE DISCARDED AT THE FACILITY. SUPPLIER CONFIRMED THAT THE GUIDES WERE MANUFACTURED TO THE SURGEON'S PRESET PREFERENCES; NO CHANGES TO THE PLAN WERE INITIATED BY THE SURGEON. THIS REPORT SUBMITTED FEBRUARY 15, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROCEDURE UTILIZING SIGNATURE GUIDES ON (B)(6) 2011. THE SIGNATURE PLAN CALLED FOR A 10MM BEARING TO BE USED, BUT DURING THE PROCEDURE THE PATIENT WAS FOUND TO HAVE A VERY LARGE MEDIAL DEFECT, REQUIRING AT LEAST A 14MM BEARING TO GET BELOW THE DEFECT. FOLLOWING THE CREATION OF MULTIPLE TIBIAL DRILL HOLES, THE PATIENT SUFFERED A FRACTURED TIBIA ON IMPACTION OF THE TIBIAL BASE PLATE. THE FRACTURE WAS REPAIRED USING A BUTTRESS PLATE AND ONE (1) CANNULATED SCREW. THERE WAS A DELAY OF MORE THAN THIRTY (30) MINUTES IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE KNEE GUIDE - 42-422451 GUIDE, SURGICAL JWH BIOMET ORTHOPEDICS N/A 023967

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R