April 15, 2015 — Smith & Nephew has been hit with a lawsuit by a woman from Illinois who says the Genesis II knee replacement is defective, according to Law360.
In July 2014, medical scans confirmed that the knee implant failed and revision surgery was recommended. She continues to endure a lengthy rehabilitation process and still has problems that prevent her from performing everyday activities.
She is seeking more than $50,000 in damages and said Smith & Nephew “showed a complete indifference or conscious disregard for the safety of others.”
The Genesis II was allegedly brought to market under the FDA’s 510(k) approval process, which allows manufacturers of new devices to avoid conducting new clinical trials so long as the new device is “substantially equivalent” to an older, FDA-approved product.
According to the complaint:
“As a result of the defective Smith & Nephew device, in addition to other damages, Snead incurred medical expenses, experienced severe pain and suffering, and has been forced to undergo a lengthy and protracted rehabilitation process.”
Oxinium Genesis II Recall
In September 2003, Smith & Nephew recalled two cementless knee replacements, the Oxinium Profix II and Oxinium Genesis II. The company received 30 reports of people who received the implants without bone cement and had to undergo revision surgery after they loosened prematurely, according to The Guardian.