Attune Knee System

Johnson and Johnson subsidiary DePuy Synthes is one of the largest manufacturers of artificial orthopaedic implants and components used to partially and totally replace knee joints. One of these implants is the Attune Knee System. However, in recent years, DePuy Synthes has filed a number of reports with the US Food and Drug Administration reporting premature failure of the Attune Knee System which has resulted in the need for revision surgeries.

The Attune Knee System was approved by the FDA as a replacement option for patients with knee arthritis, injury, and excessive wear and tear. Introduced by DePuy Synthes in March 2014, the Attune Knee System includes a number of components, including the Attune Gradius Curve, Attune Rotating Platform Knee, and the Anatomic Patella.

The rotating platform was designed to address feelings of instability when descending down stairs and bending in knee replacement patients. The rotating platform was designed to provide an enhanced range of motion and improved stability and to reduce stress and wear on the implant.

Studies have shown that 10 to 20 percent of knee replacement patients were not completely satisfied with their knee replacement. DePuy Synthes designed the anatomic patella to wrap around the knee more naturally and improve patella tracking.

As with any invasive surgery, there are risks of complications from anesthesia and the surgery itself. Specific knee replacement side effects are:

Common

The most common side effects from knee replacement surgery are, swelling, bleeding, stiffness, pain and soreness, blood clots, and nerve and tissue damage. Side effects of anaesthesia include: vomiting, dizziness, shivering, sore throat, aches and pains, and discomfort.

Serious

The serious side effects of anesthesia include: dental trauma, swelling of the windpipe, allergic reactions to latex, wheezing, vocal cord injury, stomach problems, and injuries to the arteries, veins, or nerves.

Serious complications of knee replacement surgery are blood clots, nerve and artery damage, heart attack or stroke, infections, allergic reactions, the kneecap moving away from the tibia (shin) after surgery, and bone fractures during surgery.

The most challenging complication is the loosening of the implant due to either a faulty implant or poor positioning. Symptoms associated with premature failures of the Attune Knee System include:

• Instability and Loosening
• Unusual Swelling
• Decreased Range of Motion
• Persistent Pain
• Fractures of the bone around the knee replacement.

Premature failure will require revision surgery which can be painful and has its own complication risks.

Depuy Synthes has filed numerous reports with the FDA documenting the premature failure of the Attune knee system, citing destabilisation in the patient’s knees and the requirement for revision surgery.

In an article published in the Journal of Knee Surgery, nine prominent orthopedic surgeons reported that they have encountered an unusually high-rate of premature failures of the Attune Knee System. They said the failure was caused by the debonding of the tibial implant-cement interface, which leads to the tibial component  loosening and the entire knee replacement becoming destabilized.

In most cases, the only medical solution for patients who experience a premature failure of their Attune Knee System is to undergo a revision surgery to remove the implant and replace it. These revision surgeries are often more painful and invasive than the initial replacement surgery.

In July 2015, the FDA issued a recall for over 3000 Attune Knee Tibial Articulation Surface instruments. The recall revealed the potential for the parts of the knee replacement components (the Baseal–a small wire spring coil which secures components of the knee) to become damaged and disassociate (come off). By June 2017, the FDA had received around 1400 reports involving failure of the Attune Knee System–including 633 cases where patients had needed revision surgery.