BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAMIX

    MDR report key: 413115 · Received August 28, 2002

    Report

    Report Number
    413115
    Event Type
    Malfunction
    Date Received
    August 28, 2002
    Date of Event
    May 7, 2001
    Report Date
    August 19, 2002
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT TOTAL KNEE REPLACEMENT IN 2001 FOR DEGENERATIVE JOINT DISEASE. CERETEC SCAN DONE 2 WEEKS LATER POSITIVE FOR IMFLAMMATORY PROCESS PREDOMINANTLY IN THE SOFT TISSUE SURROUNDING THE LEFT KNEE JOINT. IN 2001, IT WAS NOTED THAT THE DEPUY VACUUM MIXING BOWL SETS THAT WERE IN OR INVENTORY WERE NON-STERILE ITEMS. (PACKAGE IMPRINT-"STERILE UNLESS OPENED OR DAMAGED") LABEL ON PACKAGE-"SAMPLE (NON-STERILE). NM INDIUM SCAN IN 4/02-CONSISTENT WITH OSTEOMYELITIS INVOLVING DISTAL LEFT FEMUR & PROXIMAL LEFT TIBIA. SURGICAL HISTORY AND PHYSICAL OF 5/01 STATES "HISTORY OF FIBROUS DYSPLASIA OF TIBIA, WHICH COULD RESULT IN HIGHER FAILURE RATE IF DEGENERATIVE JOINT DISEASE & MAY END UP EVENTUALLY WITH AMPUTATION ABOVE THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAMIX VACUUM MIXING BOWL JDZ DEPUY ORTHOPAEDICS, INC. * UE5AG400

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other