Steve Sakoulas had surgery in 2008 to implant a DePuy Synthes’ ASR metal-on-metal artificial hip, the report said. According to his lawsuit, filed Dec. 6 in the U.S. District Court for the Western District of Missouri, the company started receiving reports of device failures months after its 2005 launch.
The lawsuit alleges DePuy Synthes used a loophole in FDA regulations to take the artificial hip to market skipping clinical trials saying its design was “substantially equivalent” to other hip products. Mr. Sakoulas’ lawsuit states the company’s hip device was different since it used a plastic cup instead of a metal cup in its design.
Mr. Sakoulas underwent revision surgery in December 2022, and his surgeon noticed signs of corrosion in the device’s femoral head-neck junction, according to the lawsuit. His lawsuit is seeking damages from the medical costs, pain, emotional distress and potential long-term injuries.
Kansas City Business Journal couldn’t reach DePuy Synthes for comment, and the devicemaker hasn’t filed a response to the lawsuit.
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