Cartiva Inc., a medical device company focused on treating arthritis of the big toe, and its corporate parents were hit with a lawsuit alleging its synthetic cartilage implant was defectively designed and didn’t comply with post-approval requirements.
Cathy Coleman says her implant failed because the hydrogel used in her device degraded and caused the device to shrink, loosen, and migrate into bone. Cartiva suppressed information about the devices failure from the Food and Drug Administration and the implant’s pre-market approval was largely based on a flawed study, the complaint filed Monday in the US District Court for the Western ...
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