April 15, 2015 — A woman who says she was injured by a defective knee replacement has filed a lawsuit against the manufacturer, Smith & Nephew.
She was implanted with the device at a hospital in Joliet, Illinois, in November 2011. Soon afterward, she began experiencing pain and discomfort. In July 2014, doctors performed a medical scan, confirmed that confirmed the implant failed, and recommended revision surgery.
She now accuses Smith & Nephew of negligence:
“Smith & Nephew conducted an improper act by concealing from Snead their knowledge of the negligent design and manufacture … [and] exhibited a complete indifference to or conscious disregard for the safety of others.”
The Genesis II was allegedly approved by the FDA with a 510(k) application, which allows new devices on the market so long as they are “substantially equivalent” to another device that has already been approved.
Smith & Nephew Recalls Oxinium Genesis II Knee Replacement
Smith & Nephew recalled the Oxinium Genesis II knee replacement in September 2003. According to The Guardian, 30 out of 3,000 people who were implanted with the device needed revision surgery after it loosened prematurely and failed.