BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOTAL KNEE REPLACEMENT (3 COMPONENTS)

    MDR report key: 539371 · Received August 6, 2004

    Report

    Report Number
    539371
    Event Type
    Other
    Date Received
    August 6, 2004
    Date of Event
    July 26, 2004
    Report Date
    August 6, 2004
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    TOTAL KNEE REPLACEMENT DONE. SEVERAL WEEKS LATER THE PATIENT FELL AND SURGICAL WOUND OPENED. THE PATIENT DEVELOPED FEVER AND PAIN OVER THE KNEE. WOUND CULTURE POSITIVE FOR MRSA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, AND DECISION MADE TO EXPLANT THE DEVICE DUE TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL KNEE REPLACEMENT (3 COMPONENTS) TOTAL KNEE REPLACEMENT JWH DEPUY ORTHOPAEDICS, INC. * 1440054E
    2 * TOTAL KNEE REPLACEMENT JWH DEPUY ORTHOPAEDICS, INC. * 1190792
    3 * TOTAL KNEE REPLACEMENT JWH DEPUY ORTHOPAEDICS, INC. * 228342R

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO OTHER THERAPIES