The Attune Knee lawsuits claim this medical device was defectively designed by DePuy Synthes so that its surgical glue would not properly hold the device to the patient’s tibia bone causing premature failure, immense pain, and loss of mobility.
Our law firm is accepting clients who received an Attune Knee replacement system, and who have suffered injuries from it, including loss of mobility, severe pain, infections, or revision surgery.
We have been handling lawsuits against medical device manufacturers since 1955, and each year we teach more than 1,000 attorneys how to successfully handle these types of cases. We are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
Why Are Attune Knee Lawsuits Being Filed
Attune Knee Systems have been failing at a higher rate than expected. The failure is occurring because the medical device was designed with too smooth a surface so that medical glue has difficulty holding the Attune Knee to a patient's tibia bone. Testing shows the Attune Knee is 75% smoother than previously designed knee replacement prosthetics.
The Key Legal Issue
The Attune Knee was negligently designed with an abnormally smooth metal surface. Medical glue cannot stick to it, which prevents the knee replacement prosthetic from staying in place.
Because the glue-like substance (similar to cement) cannot adhere to the Attune Knee replacement, the medical device comes loose from the patient’s tibia bone, which results in extreme pain and limited mobility. This failure often is occurring within two years after surgery, even though the device should last at least 12 years, and often up to 20 years.
What is Causing the Attune Knee to Fail
A total knee replacement is considered a major surgical procedure. The knee is the largest and hardest-working joint in the body. The orthopedic surgeon removes the damaged knee joint and replaces it with a prosthetic joint, usually made from metal, ceramic, or plastic. The ends of the femur (thigh bone) and tibia (lower leg) must be removed and cut to shape in order to receive implants that mimic the natural shape of the joint.
In order to adhere the implant to the patient's natural bone, a special type of adhesive cement is employed. The failure of this adhesion process is the primary issue behind the alarming failure rate of the DePuy Attune system.
In June 2017, a study was published in the Journal of Knee Surgery in which the researchers found that the cement-to-implant interface involving Attune Knee implants had come loose. Of the fifteen failures discovered, however, only two had been seen on x-ray images. This means that doctors could not have known of thirteen of the failures without first removing the device based on the patient's symptoms and complaints.
There are a number of reasons why the researchers found the glue was not holding. One of these is the limitations of the polyethylene plastic component in the Attune Knee, which is causing greater load-bearing stress on the interfaces. Another reason is the “roughness factor” of the components in the medical device. A relatively rough texture is necessary in order to hold the adhesive in place. In the case of the Attune Knee System, this “roughness factor” is only 60, whereas similar devices can have a roughness factor of up to 220.
Attune Knee Injuries
Knee replacement surgery usually requires a hospital stay of 4 to 5 days, and an initial recovery period of six weeks. However, full recovery can take six months to a year. The new joint should then be good for a minimum of 12 years, and up to 85% of the devices can last for 20 years or more.
When a knee replacement fails prematurely, it can result in a number of serious complications, which can include:
- Blood clots
- Bone loss
- Inflammation and swelling
- Loosening of the joint
- Loss of mobility
- Loss of range of motion
- Nerve damage
- Persistent Pain
- Warmth or heat in the knee
In these cases, the patients often have to undergo revision surgery as well as extensive rehabilitation.
Compensation in an Attune Knee Lawsuit
If your Attune Knee failed, we will be seeking the following damages for you as part of your Attune Knee lawsuit:
- Past and future medical expenses to treat your failed knee replacement, including treatment for revision surgery, infections, physical therapy, occupational therapy, and all other related medical expenses.
- Past and future pain and suffering that results from the defective Attune Knee, both from a physical and mental standpoint.
- Wage loss, if any.
- Other economic losses experienced because of the failed knee replacement, such as hiring people to perform tasks that you would have been able to perform if the Attune Knee had worked as intended.
- Punitive damages, if appropriate.
Attune Knee Settlement Amounts
As of this time, there have been no large mass tort settlements involving the high failure rate of the Attune Knee replacements. Generally, however, large groups of settlements do not occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.
In 2013, DePuy did pay approximately $2.5 billion to settle 8,000 lawsuits involving its defective ASR Hip Implant.
Recently, DePuy launched a new version of the Attune Knee called the S+ which is designed with a non-smooth surface. This likely was done because DePuy recognizes that it's older design was faulty, even though DePuy defends the previous version and attacks researchers who have claimed its defective.
Daniel Nigh Discusses the Attune Knee Lawsuits
Attune Knee Recalls
As of this time, there has not been a recall of the Attune Knee related to its higher than expected failure rate. However, when DePuy applied for FDA pre-market approval for the Attune Knee in 2010, DePuy stated that the Attune Knee was “substantially equivalent” to Zimmer Biomet NexGen CR Knee System. This knee replacement system was recalled in January 2016 due to an abnormally high failure rate.
In 2010, DePuy recalled its ASR metal-on-metal hip implants due to unusually high failure rates. More than 9,000 individuals filed lawsuits against the company as a result of injuries sustained.
Additionally, between 2002 and 2013, DePuy Synthes recalled 277 knee implant devices and components because the devices were loosening and failing prematurely. In 2015, the company recalled its Attune Articulation Surface component because a spring coil could break off during surgery and enter the patient’s body.
Why Are Total Knee Replacement Surgeries Performed
Knee arthroplasty, or replacement, is the most commonly-performed bone operation in the United States, with over 600,000 procedures being performed annually. In most cases, knee arthroplasty is indicated for age-related conditions such as arthritis, which weaken and/or destroy the cartilage surrounding the knee.
Most candidates for knee arthroplasty are age 45 or older. However, it is also indicated for patients who have suffered injuries, such as a broken bone or torn ligament, or have knee deformities (“knock knees” or bowed legs).
Knee replacement surgeries have been carried out successfully since 1968. For the majority of patients, a total knee replacement should last twenty years. According to the American Association of Hip and Knee Surgeons, knee replacements have an annual failure rate of less than 1%. Most of these are caused by other complications, such as infection. Rarely is it caused by the device itself.
Attune Knee Lawsuit News
First U.S. Lawsuit Filed Against DePuy-Synthes for Attune Knee Replacement Failure
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. The surgeons attributed the failures to the debonding of the tibial implant-cement interface. Reported in Orthopedic Design and Technology
Report: DePuy’s Attune knee seeing “unusually high” rate of early failure
“Patients presented with pain on weight bearing, effusion and decreased range of motion (ROM) within 2 years after surgery. Radiographic evaluation demonstrated loosening of the tibial components in 2 of 15 knees. This included cruciate retaining, posterior stabilized, fixed bearing and rotating platform bearing designs,” study authors wrote. “Intraoperative findings demonstrated gross loosening of the tibial component at the implant-cement interface.” Reported in Mass Device