Robert C. Hovey filed suit on Wednesday in the Middle District of Florida against Tracpatch Health Inc. The complaint alleges that the defendant designed, developed, and serviced the plaintiff with a hip replacement device that was defective and unreasonably dangerous.
The plaintiff selected the defendant’s product, the Consensus Hip System, as their replacement for their damaged natural hip. The consensus hip system was cleared by the Food and Drug Administration under Section 510(k) of the Food, Drug, and Cosmetic Act, meaning that it did not have to go through any clinical study to gain clearance by the agency. The complaint explains that this pathway “allows devices to avoid clinical study and any testing for safety or efficacy.”
Hovey argues that defendant Tracpatch knew, or should have known, that this pathway did not adequately assess the efficacy and safety of their product. Hovey contends that if Tracpatch had undergone reasonable premarket testing, they would have discovered their product’s “unreasonable propensity to harm patients, consistent with the harm Plaintiff experienced.”
The plaintiff explains that the system’s flawed design led to him experiencing fretting and corrosion of the trunnion, which ultimately resulted in heavy metal poisoning. When the corrosion process wore completely through, Hovey had no skeletal connection between his torso and his leg, a phenomenon called catastrophic dissociation.
Hovey claims that Tracpatch should have been aware that “the poor design and material choices of the defendant’s consensus hip system would lead to micro-motion, fretting, corrosion, and ultimately the total failure of the implant.”
The complaint cites strict liability failure to warn, strict liability design and manufacturing defect, negligence, and breach of warranty. Plaintiff Hovey is seeking damages, litigation fees, a trial by jury, and any other relief deemed just by the Court.
The plaintiff is represented by Maglio Christopher & Toale.
