Zimmer knee replacement lawsuit law firm authored article
The Zimmer Persona knee replacement system was on the market for just over two years. The Persona was intended to act as a revolutionary knee replacement, allowing doctors to “personalize” the joint for the patient. Failures in the system led Zimmer to pull the product from the market not long after its introduction. In the wake of the recall, Zimmer is facing hundreds of product liability lawsuits that accuse it of selling a defective knee replacement.
What is the Persona Knee Replacement?
The Persona knee replacement (Personalized Knee System) was introduced to the market in 2012. The product went through the FDA’s 510k process, meaning that the FDA’s approval did not require extensive testing on the product before it was sold. This express approval came due to the product’s similarity to another legally approved product already on the market. The product was sold to patients who needed a knee replacement due to problems stemming from arthritis or avascular necrosis.
Persona was intended to better fit different types of knees by matching the implant to the exact characteristics of the resected bone. The customizable fit was supposed to help patients better reestablish the proper alignment in their knee after the replacement surgery. Persona included a wide variety of different component sizes, shapes, and constraint options so that the best fit could be achieved by some combination of these parts.
Complications from Persona
However, a little more than two years after the Persona was introduced to the market, the FDA issued a recall notice for the system. The recall notice was issued after reports that patients were experiencing a loosening of the device after the surgery as well as other defects. According to one of the lawsuits filed against Zimmer, the recall affected nearly 12,000 devices that were sold to doctors and hospitals.
Specifically, patients were encountering radiolucent lines in their replacement devices. This occurs when the new knee is not properly seated and there are gaps between the existing bone and the new knee. This means that the knee replacement is not remaining in place, causing patients pain and discomfort. The loosening of the replacement joint can lead to cartilage loss, surface and tissue. A loosened knee replacement ultimately means that patients will have to undergo a subsequent knee replacement in order to receive a new, properly functioning knee. After the FDA recall, Zimmer pulled this particular model of Persona from the marketplace although Zimmer continues to sell other replacements under the Persona brand name.
Persona Product Liability Lawsuits
After the FDA recall, Zimmer has faced hundreds of lawsuit regarding the alleged defects in Persona. This was after Zimmer also defended lawsuits stemming from another knee replacement product named NexGen. These lawsuits began to be filed in 2016, after the product was recalled from the market.
The lawsuits generally allege that Zimmer designed and marketed a defective product. Specifically, the plaintiffs seek to hold Zimmer strictly liable for a defective product. It is alleged that the product was defective because its design caused a propensity that the product would loosen once it was inserted into the knee. In addition, the design resulted in a likelihood that the device would have radiolucent lines, causing the replacement to fail.
According to the plaintiffs, Zimmer knew, or had reason to know, that the design and composition of the Persona knee replacement would cause it to fail in this manner. Zimmer had an obligation to warn patients of these dangers, but failed to do so. As the manufacturer of these products who purportedly tested them prior to selling them to the public, Zimmer should have known of the dangers.
The lawsuits also claim that the Persona knee replacement was not on, defectively designed, but improperly manufactured as well. Had this product been properly manufactured, the knee replacement would have remained in place. In addition, Zimmer is also alleged to have been negligent in both the design and manufacture of this product. The lawsuits all allege a violation of certain specific state consumer laws of the state in which they were filed. These claims are still early in their lifecycle and will not reach trial for several years to come.
Zimmer has a long history of defending knee replacement lawsuits, although the FDA recall here is a clear indication that something is wrong with this particular medical device. If you have received a knee replacement that involves the implantation of a Persona personalized system, you should contact a Zimmer knee replacement lawsuit lawyer immediately, even if you do not yet feel any pain from your knee replacement. This is because there is a not insignificant chance of requiring a further surgical procedure which can cause you both time and money. A Zimmer knee replacement lawsuit lawyer can discuss your legal options with you, including the chance that you may have to receive compensation for your claim.