BEUDAMED
    FDA Adverse Event Death Summary report: N

    WRIGHT MEDICAL

    MDR report key: 791323 · Received November 30, 2006

    Report

    Report Number
    791323
    Event Type
    Death
    Date Received
    November 30, 2006
    Date of Event
    October 4, 2006
    Report Date
    November 27, 2006
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    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 A WEEK LATER WITH SEPTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIGHT MEDICAL TIBIAL BASE 2 STD HSH WRIGHT MEDICAL * 086373627
    2 WRIGHT MEDICAL POLY PATELLA, 35MM HTG WRIGHT MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death