BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAMIX VAC MIX BOWL N/S SAMP

    MDR report key: 405905 · Received July 12, 2002

    Report

    Report Number
    1818910-2002-00380
    Event Type
    Injury
    Date Received
    July 12, 2002
    Date of Event
    May 21, 2001
    Report Date
    July 12, 2002
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    LEGAL PAPERS STATE THE PT DEVELOPED POST OPERATIVE INFECTION FOLLOWING A TOTAL KNEE PROCEDURE IN 2001. THE ATTORNEY ALLEGES THE MIXING BOWL FOR THE CEMENT USED WAS NOT STERILE; RESULTING IN INFECTION IN THE PT'S KNEE AND FEMUR. PT WILL BE SCHEDULED TO REMOVE THE IMPLANTS; UNDERGO A PERIOD OF MEDICATION AND THEN UNDERGO A THIRD SURGERY TO REPLACE THE PROSTHESES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAMIX VAC MIX BOWL N/S SAMP MIXING APPARATUS JDZ DEPUY ORTHOPAEDICS, INC. NA UE5AG4000

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R