BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAMIX

    MDR report key: 405893 · Received July 12, 2002

    Report

    Report Number
    405893
    Event Type
    Malfunction
    Date Received
    July 12, 2002
    Date of Event
    May 21, 2001
    Report Date
    July 8, 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

    OR IN 2001, LEFT TOTAL KNEE ARTHROPLASTY FOR PAIN, SWELLING, KNEE LOCKED UP, ETC, THAT WAS NOT RELIEVED BY ANTI-INFLAMMATORY MEDICATIONS AND DECREASED ACTIVITY. TWO MONTHS LATER, IT WAS DETERMINED THAT THE DEPUY VACUUM MIXING BOWL SETS THAT WERE IN INVENTORY WERE NON-STERILE ITEMS. (PKG IMPRINT-"STERILE UNLESS OPENED OR DAMAGED"). LABEL ON PACKAGE - "SAMPLE (NON-STERILE)". PER SURGEON'S H&P, PT HAD AN MRI, WHICH SHOWED AVASCULAR NECROSIS OF BOTH KNEES. LEFT SHOWS AVN IN BOTH MEDICAL AND LATERAL FEMORAL CONDYLES OF THE LEFT KNEE. RIGHT SHOWS AVN MORE PREDOMINANTLY ON THE RADIAL AS OPPOSED TO THE LATERAL FEMORAL CONDYLES.

    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 43 YR Other