BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANCE(R) II TIBIAL BASE

    MDR report key: 789822 · Received November 30, 2006

    Report

    Report Number
    1043534-2006-00124
    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
    PMA / PMN Number
    K960617
    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. ADDITTIONAL INFORMATION HAS BEEN REQUESTED FROM THE SURGEON AND THE USER FACILITY. A MEDWATCH 3500A FORM HAS BEEN RECEIVED FOR THE USER FACILITY. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 10435342006-00125, 00126, 00127.

    Description of Event or Problem · 1

    DEATH 2006. PER MEDWATCH 3500A, "PATIENT UNDERWENT TKR. SHE WAS READMITTED TWENTY-THREE DAYS LATER. WITH SEPSIS OF THE RIGHT TKR WITH PATELLAR TENDON RUPUTRE. 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 TEN DAYS LATER WITH RIGHT KNEE INFECTED PROSTHESIS WITH SEPTIC ARTHRITIS. SHE UNDERWENT RADICAL RESECTION OF THE SOFT TISSUE AND BONE 2 DAYS LATER. SHE RETURNED TO SURGERY FOUR DAYS LATER FOR RIGHT AKA. SHE EXPIRED A WEEK LATER WITH SEPTIC SHOCK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE(R) II TIBIAL BASE HRY HSH WRIGHT MEDICAL TECHNOLOGY, INC. * 086373627

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death