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The Attune Knee lawsuits being filed against DePuy Synthes claim the medical device was defectively designed so that surgical glue would not properly hold the device to the patient’s tibia bone.
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 glue will not properly stick. Testing shows the Attune Knee is 75% smoother than previously designed knee replacement prosthetics.
When the glue fails, the Attune Knee comes loose from the patient’s tibia bone, which results in extreme pain and limited mobility, and possibly a severe infection. 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.
When the Attune Knee was first introduced in 2011, DePuy’s marketing department claimed it was the end product of “one of the largest research and development projects in the history of DePuy Synthes Joint Reconstruction,” bringing together “the latest in design, kinematics, engineering and materials to deliver stability and motion.”
However, when DePuy applied for FDA pre-market approval for the “new” device in 2010, it was claimed that the Attune System was “substantially equivalent” to products already being sold, one of which was the NexGen CR Knee System from Zimmer Biomet, which was subject to a Class 2 Recall in January 2016.
In 2016, DePuy announced “new clinical evidence of the positive performance of the Attune Knee System.” The company quoted Dr. David Fisher as saying: “One short-term study demonstrated improved patient outcomes as compared to another leading knee system, including less pain, better motion, and increased function. Another study showed shorter hospital length of stay, which has important implications for the care trajectory and costs.” It should be noted that Dr. Fisher was a paid consultant for DePuy.
Despite Dr. Fisher’s statements about the great outcomes with the Attune Knee, a growing number of reports have been submitted to the FDA’s Manufacturer and User Facility Device Experience database (MAUDE), indicating a high rate of premature failure. These reports appear to show that there is a lack of adhesive on the baseplate of the device, which is attached to the top of the tibia (“shin bone”). Normally, these components require a roughened surface in order for the glue to hold. Upon removing these components, doctors have found them to be “completely smooth.”
In June 2017, a study was published in the Journal of Knee Surgery. In all 15 cases studied, the researchers found that the cement-to-implant interface had come loose, even though only two of the cases could actually be seen by x-ray images.
There are a number of reasons why this is occurring. 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 explanation 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 that of the previous generation device was 220.
We will be seeking the following damages for you:
As of this time, there have been no large group 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.
Our law firm has been in existence for more than 60 years, and is considered a national leader in this type of litigation. We have received well over 150 jury verdicts throughout the country in the amount of $1 million or more, and achieved verdicts and settlements in excess of $4 billion.
We are the founder of Mass Torts Made Perfect, which is a national seminar attended by approximately 800 lawyers twice per year where we help teach the successful handling of cases against medical device companies. For more information, please visit our About Us section.
Our lawyers provide absolutely free confidential consultations, and if we are fortunate enough for you to hire us, we never will charge you any fees or costs unless you first recover. To review a summary of our fees and costs, click Fees & Costs.
To contact us for a free confidential consult, you can call us at (800) 277-1193 (toll free). You also can request a confidential consultation by clicking Free & Confidential Consult, which form will be immediately reviewed by one of our attorneys handling the Attune Knee litigation.
A class action is a type of lawsuit where a few individuals represent the interest of many other individuals. The court rulings are binding on all persons who are considered a member of the class action. All class members are required to accept the settlement approved by the court, even if an individual class member is going to receive little or no compensation.
This is not the type of litigation we will be pursuing for our Attune Knee clients. Instead, we represent each individual based on his/her specific circumstances, and evaluate the recovery for each client based on his/her facts. Each of our clients always has the option of settling or not settling his/her case.
For a detailed discussion on class actions, mass torts, and multidistrict litigation, please visit our Class Action Mass Torts Page.
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.
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, and requires extensive physical therapy. The new joint should then be good for a minimum of 12 years, and in up to 85% of cases 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:
In these cases, the patient must invariably undergo revision surgery as well as extensive rehabilitation.
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.
A novel design total knee arthroplasty (TKA) system has been introduced to improve patient outcomes and increase longevity. However, we have encountered a high rate of debonding of tibial implant–cement interface. In addition, multiple reports have been filed in Manufacturer and User Facility Device Experience database with the same mechanism of failure. Reported in The Journal of Knee Surgery – Attune Knee Failures
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.
Additionally, between 2002 and 2013, DePuy Synthes recalled 277 knee implant devices and components, and 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.
Levin Law