BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIPLE VENDORS

    MDR report key: 1081419 · Received July 24, 2008

    Report

    Report Number
    MW5007792
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    July 24, 2008
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I AM A HEAD AND NECK SURGEON; I HAVE BEEN SEEING INCREASED NUMBERS OF PTS WITH LYMPHOMA. OUR LOCAL MEDICAL LIBRARIAN FOUND A NUMBER REFERENCES IN THE OTHER COUNTRY'S ORTHOPEDIC LITERATURE ABOUT A POTENTIAL ASSOCIATION OF LYMPHOMA WITH METAL-ON-METAL ARTHROPLASTY IMPLANTS IN OSTEOARTHRITIS PTS TO BE DISTINGUISHED FROM THE WELL DOCUMENTED INCREASED INCIDENCE OF LYMPHOMA IN RHEUMATOID ARTHRITIS PTS. THESE ARTICLES SUGGEST METAL WEAR OF 5 MICRONS PER YR WITH THE METALS DISSEMINATED THROUGHOUT THE BODY WITH SOME CASES OF SIGNIFICANTLY ELEVATED LEVELS OF CHROMIUM, COBALT ETC. DEPENDING UPON THE ALLOY OF THE IMPLANT. A SIMILAR SEARCH OF THE US LITERATURE DELINEATED NO SUCH LITERATURE. ONE ORTHOPEDIST SUGGESTS THAT THE CURRENT NUMBER OF NEW LYMPHOMA CASES ASSOCIATED WITH METAL ON METAL ARTHROPLASTY IMPLANTS MAY BE ONLY THE "TIP OF THE ICEBERG." ARE WE MISSING SOMETHING HERE IN THE US? I HAVE 2 PTS CURRENTLY IN THE DIAGNOSTIC PROCESS BOTH WITH LYMPHOMA, BOTH OF WHOM HAVE HAD MULTIPLE METAL ARTHROPLASTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPLE VENDORS ARTHROPLASTY IMPLANTS HSD

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening