BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE REPLACEMENT

    MDR report key: 3416221 · Received October 11, 2013

    Report

    Report Number
    MW5032259
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    April 29, 2013
    Report Date
    October 10, 2013
    Manufacturer
    BIOMET
    Product Code
    NRA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A PARTIAL KNEE REPLACEMENT WITH THE OXFORD KNEE SYSTEM ON (B)(6) 2013 AND APPROXIMATELY ONE MONTH LATER DEVELOPED HIVES ALL OVER MY BODY. I WAS SEEN BY AN ALLERGIST, WHO PERFORMED ALLERGY TESTING, AND FOUND OUT I AM ALLERGIC TO COLOPHONY, WHICH IS A CHEMICAL USED IN POLYETHYLENE, WHICH IS WHAT THE PLASTIC PART OF THE KNEE IS MADE FROM. I AM STILL BREAKING OUT IN HIVES, HAVE BEEN TO THE EMERGENCY ROOM THREE TIMES BECAUSE THEY WERE SO BAD I COULD NOT BREATHE. I AM TOLD THAT NO ONE HAS EVER HEARD OF A REACTION TO THE PLASTIC AND AM UNCERTAIN IF THERE IS ANYTHING THAT CAN BE DONE AS NO ONE HAS GIVEN ME ANY OTHER OPTIONS. I AM SUFFERING EVERY DAY WITH HIVES, I AM ON BENADRYL AND STEROIDS. I AM AFRAID OF THE LONG TERM EFFECTS OF BEING ON THESE MEDICATIONS AND MY QUALITY OF LIFE IS SUFFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522669 OXFORD PARTIAL KNEE REPLACEMENT OXFORD PARTIAL KNEE REPLACEMENT NRA BIOMET

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability