The U.S. Food and Drug Administration (FDA) approved the DePuy Synthes Attune Knee System in 2010, but reports of device failure quickly flooded in. Patients are experiencing premature device failure requiring painful additional surgeries. Although there has been no recall of the Attune Knee System, the FDA has received hundreds of reports of device failure and patients across the country are demanding answers.
DePuy Synthes’ Attune Knee System is a knee replacement that works with a patient’s muscles and ligaments. Patients suffering from mobility issues or who have sustained knee injuries may have a knee replacement surgery to help increase range of motion and use. The Attune Knee System is comprised of three parts: the Gradius Curve, Glideright Articulation, and AOX Polyethylene. These components act together to imitate the natural movement of the knee.
When the FDA approved the Attune Knee System in 2010, it was under the controversial 501(k) approval process. Under this process, new devices similar enough to existing approved devices don’t have to undergo strenuous clinical trials for approval. Because the Attune Knee System was similar to other knee implants already on the market, manufacturer Depuy Synthes did not have perform as many studies and tests to prove the device’s safety and effectiveness.
Since its approval in 2010, the FDA has received hundreds of reports of complications via its Adverse Event Reporting System. Many reports include patients who needed additional revision and/or reconstructive surgeries after their knee implant procedures. Depuy Synthes itself has filed dozens of reports with the FDA that illustrate premature device failure. In total, the FDA has received 232 Attune Knee adverse event reports.
Attune Knee lawsuits claim DePuy Synthes defectively designed the medical device in such a way that its surgical glue does not properly hold the device to the patient’s tibia bone, causing premature failure, immense pain, and loss of mobility. The failure is occurring because the medical device was designed with a surface too smooth for the surgical glue to stick. Testing shows the Attune Knee is 75% smoother than previously designed knee replacement prosthetics.
A recent article published in the Journal of Knee Surgery included the concerns of nine prominent orthopedic surgeons who reported unusually high rates of premature device failure with the Attune System. The surgeons attribute premature failure to a loosening of the part of the system connected to the tibia. This loosening causes the entire implant system to destabilize.
Thousands of patients have been implanted with the Attune Knee System and could face painful symptoms of failure. While most implants are designed to last approximately 15 years, patients with the Attune Knee System are experiencing failure in the first few years after implantation.
Signs your Attune Knee System has failed can include:
For patients suffering injuries after the implantation of a defective Attune Knee System, additional surgeries are required to remove and replace the implant. Some patients undergo revision surgeries, which are more challenging and painful than the initial surgery because the faulty device must be explanted – or broken away from the leg bones. Revision surgeries can cause muscle or nerve damage, bone loss, infections, and other serious complications. Some patients must undergo reconstructive surgeries after the implant has severely damaged the surrounding bones. The knee joint may even have to be surgically rebuilt so that a new replacement joint can be implanted.
Thousands of patients have suffered terrible injuries from the Attune Knee System. Patients were not adequately warned of the potential for premature failure of the device and they are looking to hold DePuy Synthes, a subsidiary of healthcare giant Johnson & Johnson, responsible for negligence. In September 2017, the first Attune knee replacement lawsuit was filed in Alabama. It is anticipated many more lawsuits will be filed in the coming months as patients demand answers.
In the United States, a tort refers to a, “body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others.”
An MDL stands for multidistrict litigation and is a special legal procedure conducted in federal court that is designed to quickly conduct the handling of complex cases, which can include dangerous drug and medical device lawsuits.
It means the manufacturer made an error either in the design or the fabrication of a product that causes it to not work as intended. This can be especially dangerous in many cases, such as those of faulty medical devices and prescription drugs.
A defective design in a product is one that is so great, the product cannot be utilized for the purposes intended or is even made hazardous as a result of the defect, imperfection, or design flaw. In the case of medical devices, this can be a deadly mistake.