Attune Knee System Lawsuits

DePuy Synthes, a Johnson & Johnson subsidiary, is one of the world’s largest manufacturers of artificial knee implants. Their Attune Knee System is the subject of personal injury and product liability lawsuits over claims of defective devices requiring intensive intervention.

Patients who underwent knee replacement surgery with the Attune Knee System are suing DePuy Synthes, claiming that injuries were caused with the implant and they were not sufficiently warned about the unreasonably dangerous character of the system.

Plaintiffs report that shortly after surgery, they experienced severe knee pain, knee instability and had difficulty walking — all signs of premature failure of a knee replacement. In their lawsuits, patients allege that the Attune Knee System was defective in design, caused loosening of the tibial baseplate; contained defective cement, which led to pain, infection, inflammation, bone and muscle damage; and in many cases resulted in the need for painful revision surgery. Further allegations are made that DePuy Synthes knew, or should have known, that there were design problems with the Attune Knee System but continued to market the product, putting more patients at risk.

Many experts have found that there is an unusually high rate of early failures in the DePuy Synthes Attune Knee System. By June 2014, the FDA had already received 1,400 reports (in its Manufacturer and User Facility Device Experience, or MAUDE, database) about the failures of the device. Of those reports, 633 patients required revision surgery. By comparison, for the Persona knee replacement system, also manufactured by DePuy Synthes, approximately 384,000 devices have been implanted, and the FDA database has a collection of only 183 reports of device failures with 64 of these resulting in revision surgeries.

DePuy Synthes, a subsidiary of Johnson & Johnson, is listed as the defendant in these lawsuits as the manufacturer of the Attune Knee System.

Attune Knee System Litigation

Between 2003 and 2013, DePuy had recalled 277 devices or components as part of a Class 1 and Class 2 recalls. Four recalls were in Class 1.

Class 1 recalls mean the product has flaws that could seriously harm patients. Class 2 recalls indicate a situation in which use or exposure to the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

In 2011, the FDA warned DePuy Synthes that the company was marketing several products that had not received FDA approval, and that several devices had been altered and were misbranded as safe and effective.

However, DePuy claimed that their devices were approved under the 501(k) process (a process by which a premarket submission is made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval). DePuy Synthes claimed that the Attune Knee System was substantially equivalent to currently marketed devices, including their earlier SIGMA Knee System. Following the 2011 FDA warning, DePuy voluntarily recalled a number of its knee replacement components.

The FDA later granted approval in August 2011 for the Attune Knee System. However, since its approval, the FDA has received thousands of complaints from patients about complications with the Attune Knee System, namely that the tibial plate loosened and was incorrectly fixed to the tibia. This required revision and reconstructive surgeries.

In 2015, the FDA recalled 3,474 units of the Attune Knee Tibial Articulation Surface Instrument. It stated that a component of the system, the Balseal, can become damaged and detached during knee replacement surgery, and remain loose inside the patient’s body if the surgeon is unaware of its detachment.

In September 2017, an Alabama law firm filed the first lawsuit alleging the premature failure of the DePuy Synthes Attune Knee System. It was filed in the Circuit Court of Tuscaloosa County, Alabama.

In October 2017, Joyce Rogers filed a lawsuit in the U.S. District Court for the Southern District of Mississippi for damages and future compensation relating to the Attune Knee System. Rogers’ lawsuit claimed the device was defective and caused severe pain, swelling, and instability in the knee and leg that was the result of loosening of the Attune Knee System tibial baseplate component, due to debonding of the baseplate-cement interface. Rogers underwent extensive revision surgery to replace the system. The lawsuit also alleges that DePuy Synthes aggressively marketed the Attune Knee System as a safe and effective knee replacement despite the high failure rate and the large number of revision surgeries that took place, that they failed to adequately warn healthcare providers of its complications, and that they failed to adequately test the implant. Rogers claims in the lawsuit that DePuy unlawfully and knowingly concealed information about the Attune Knee System failures even though they were under an obligation to do so.

It is expected that many suits will follow.