BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH AND NEPHEW

    MDR report key: 2893958 · Received December 27, 2012

    Report

    Report Number
    MW5028403
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    January 9, 2012
    Report Date
    December 27, 2012
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2007, I HAD A SMITH & NEPHEW BHR OF MY RIGHT HIP (MOM). IN (B)(6) 2009, I HAD A SMITH & NEPHEW BHR OF MY LEFT HIP (MOM). IN 2010, I EXPERIENCED A FLAIR UP OF PAIN AND LIMITATION IN MY RIGHT HIP. OVER TIME, THIS DID GET BETTER. IN (B)(6) 2011, I EXPERIENCED MILD TO SEVERE PAIN IN MY LEFT HIP, VERY SIMILAR TO MY PRE-SURGERY BONE ON BONE SENSATION. THIS ALSO EASED UP AND WENT AWAY AFTER ABOUT 2 WEEKS. ON (B)(6) 2012, I WAS DIAGNOSED WITH ACUTE RENAL FAILURE. THIS WAS DETERMINED TO BE CAUSED BY AN AUTOIMMUNE RESPONSE (VASCULITIS, ANA POSITIVE WITH GLOMERULONEPHRITIS). AFTER 8 MONTHS OF PREDNISONE USE AND 10 MONTHS OF A CHEMOTHERAPY DRUG, THE RENAL FAILURE HAS BEEN UPGRADED TO A DECREASE OF KIDNEY FUNCTION. I WAS ENCOURAGED, BY AN INDIVIDUAL WHO HAS A DEPUY IMPLANT AND HAS ELEVATED METAL LEVELS, TO HAVE MY METAL LEVELS TESTED. MY (B)(6) 2012 CHROMIUM LEVEL SHOWED 52.5 AND COBALT 132.1. X-RAYS AND MARS MRI SHOW NO SIGNIFICANT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH AND NEPHEW BIRMINGHAM HIP RESURFACING JDI SMITH AND NEPHEW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other