Attune Knee System

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.

What Is The Attune Knee System?

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.

Attune Knee System Approved Under Controversial Process

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.

FDA Receiving Hundreds of Reports of Failure

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.

Studies Find The Attune System Prone To Failure

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.

Symptoms of A Defective Implant

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:

  • Instability when standing or putting weight on the leg of the implant
  • The knee moves backwards or sideways
  • Unusual swelling caused by fluid build-up
  • Persistent pain
  • Warmth or heat in the knee several months after surgery

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.

Patients Fighting Back

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.