BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANCE(R) II MEDICAL-PIVOT TIBIAL INSERT

    MDR report key: 789829 · Received November 30, 2006

    Report

    Report Number
    1043534-2006-00127
    Event Type
    Death
    Date Received
    November 30, 2006
    Date of Event
    October 27, 2006
    Report Date
    November 28, 2006
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. EVENT DEVICE CODE IS ADDRESSED IN PACKAGE INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FORM THE SURGEON AND THE USER FACILITY. A MEDWATCH 3500A FORM HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2006-00124, 00125, 00126.

    Description of Event or Problem · 1

    PER MEDWATCH 3500A, "PATIENT UNDERWENT TKR IN 2006. SHE WAS READMITTED TWENTY-THREE DAYS LATER WITH SEPSIS OF THE RIGHT TKR WITH PATELLAR TENDON RUPTURE. THE PATIENT UNDERWENT RADICAL RESECTION OF SOFT TISSUE OF THE KNEE AND REVISION OF THE RIGHT TKR AND SINGLE COMPONENT, ETC. CULTURES DONE AT THE TIME OF SURGERY WERE POSITIVE FOR HEAVY GROWTH OF CLOSTRIDIUM SUBTERMINALE AND PERFRINGENS. CULTURES WERE TAKEN FROM THE RIGHT KNEE PSEUDOCAPSULE AND TISSUE. THE PATIENT WAS DISCHARGED FIVE DAYS LATER. SHE WAS READMITTED ELEVEN DAYS LATER WITH RIGHT KNEE INFECTED PROSTHESIS WITH SEPTIC ARTHRITIS. SHE UNDERWENT RADICAL RESECTION OF THE SOFT TISSUE AND BONE TWO DAYS LATER. SHE RETURNED TO SURGERY TWO DAYS LATER FOR RIGHT AKA. SHE EXPIRED NINE DAYS LATER WITH SEPTIC SHOCK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE(R) II MEDICAL-PIVOT TIBIAL INSERT KNEE COMPONENT HSH WRIGHT MEDICAL TECHNOLOGY, INC. * 03343216

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death