Since the 2010 approval of the Attune Knee Replacement System, the U.S. Food and Drug Administration (FDA) has received hundreds of reports of device failure. For many patients, the Attune implant is failing after only a few years, or in some cases, just months after implantation. Artificial joints on average last approximately 15 years before needing replacement, but Attune implant failures are causing hundreds of additional surgeries.
Components of the Attune Knee Replacement System
The Attune Knee Replacement System attempts to mimic the natural movement of the knee. Do achieve this, the device is made up of several components:
- Attune Gradius Curve – This component is designed to work with the femur and tibia where they connect at the knee joint. The smooth operation of the Gradius Curve allows patients to perform regular motions like walking.
- Glideright Articulation – The Glideright Articulation sits where the femur and the patella (or kneecap) connect, interacting with both bone and soft tissue. This particular area of the knee varies greatly in size from patient to patient, so an optimal fit is crucial for a successful recovery.
- Sofcam Contact – This curved component helps stabilize the knee when bent in deep flexion or bent all the way back.
- Logiclock Tibial Base – The tibial base is an insert into the tibia where the femur meets the tibia. This component is very important for comfort and stability and it comes in different sizes to best meet patient needs.
- AOX Polyethylene – Polyethylene is a plastic material. In the Attune Knee System, it is used as a spacer between the tibia and the femur. The polyethylene spacer replaces cartilage in the knee joint.
Where The Attune Knee Replacement Went Wrong
Many patients have experienced a loosening in their Attune Knee Replacement that causes swelling, pain, and decreased mobility. The Attune Knee Replacement is prone to loosening because of its smooth surfaces. Surgeons use a type of medical glue to attach the components to the leg bones. However, because the surface of the device is so smooth, the glue cannot hold the implant to the tibia bone.
In June 2017, a study published in The Journal of Knee Surgery explained surgeons were encountering a high number of early failures in the Attune Knee Replacement System due to tibial loosening. Not only has the FDA received reports of device failure, but scores of reports have been made to the Manufacturer and User Facility Device Experience Database (MAUDE).
Newer Versions Fix Debonding Issue
Although Attune’s manufacturer, DePuy Synthes, a subsidiary of Johnson & Johnson, has denied claims that the device is defective, the company did create a new version of the tibial base component. The underside of the new tibial base plate is not smooth, which allows better adhesion. The updated design of the Attune Knee Replacement is an indicator the manufacturer is aware of the issues and side effects caused by the knee implant.
Patients Demanding Answers
The loosening of the Attune Knee Replacement System is extremely painful for patients. Patients can suffer permanent damage to the knee joint and will require replacement surgeries to relieve pain and regain mobility. All patients have a right to know all risks associated with medical devices, and many Attune Knee Replacement patients feel the manufacturer did not warn them of the increased rate of failure. Demanding answers, the first lawsuit against DePuy Synthes and Johnson & Johnson regarding the Attune Knee Replacement was filed last September. It is likely many other lawsuits will be filed in the coming months as patients try to understand how such a dangerous device made it onto the market and into operating rooms.