When DePuy, a subsidiary of Johnson & Johnson, released the DePuy Attune Knee Replacement System in 2010, it was marketed as a device made to deliver high levels of stability and motion as well as patient satisfaction.
In the years since the system was released, mounting evidence suggests that the DePuy Attune System may be prone to premature failure.
As a result, people are beginning to file lawsuits against DePuy over claims that the manufacturer designed and marketed a defective device.
According to DePuy, patient dissatisfaction after knee replacement surgery is somewhere between 10% and 20%. The most common complaint is pain.
In order to provide a more satisfying experience with knee replacement surgery, DePuy created the Attune Knee System.
“The ATTUNE Knee System is designed to address the unmet needs of patients, surgeons, and hospital providers around the world,” DePuy writes in its value analysis brief of the device. “Extensive research and science has gone into the design to help improve functional outcomes for patients, performance for surgeons, and efficiency for providers.”
Unfortunately, evidence may point to a high rate of failure in the Attune system.
In September 2017, nine orthopedic surgeons reviewed reports of Attune device failure and said they encountered a “high rate of debonding of tibial implant–cement interface.” In other words, the glue holding the device together did not work as originally thought. This led to unexpected instability.
The study, which was published in the Journal of Knee Surgery, looked at reports submitted to the U.S. Food and Drug Administration. The Manufacturer and User Facility Device Experience (MAUDE) database collects reports from manufacturers and user facilities.
At the time, there were more than 200 reports involving the system. They also found cases of tibial loosening in a review of three hospital databases.
It was still unclear whether the failures were isolated or indications of a wider problem. Researchers warned the failure of Attune devices could be underreported, however.
“We believe that this complication is underreported due to failure of radiographs to assess loosening,” the authors warned.
Although the procedure is called a knee replacement, the American Academy of Orthopaedic Surgeons says knee resurfacing is a more accurate term since the bones themselves are not replaced.
During the operation, only the surfaces of the bone are replaced.
Total knee replacement is only recommended in cases where non-surgical options have been exhausted. If a patient suffers from severe knee pain or a deformity, a doctor will sometimes recommend the procedure.
During the procedure, the damaged cartilage is removed from the surfaces of the femur and tibia along with some bone. Then the components of the DePuy Attune system are implanted and cemented to the bone. The kneecap is also resurfaced with a plastic button. Finally, a spacer is inserted to offer a better surface for the components to work together.
The reports of failure have surrounded the tibial component of the Attune system, which is important to the stability and fit of the device.
Shortly after the study in the Journal of Knee Surgery was published, the first lawsuit related to the Attune system was filed against DePuy and Johnson & Johnson.
In a press release, Cunningham Bounds LLC announced it had filed the lawsuit in the Circuit Court of Tuscaloosa County in Alabama due to the premature failure of the system.
DePuy markets Attune as a safe and effective knee replacement option.
“However, in recent months, DePuy Synthes has filed dozens of reports with the Food and Drug Administration documenting premature failures of the Attune Knee System that have resulted in the destabilization of patients’ knee replacements and painful revision surgeries,” the firm said.
More than four million Americans are living with knee implants, according to Consumers Union. However, the rise of knee replacement surgeries has also come with a rise in device failures.
The 2013 summary of knee recalls found that DePuy had the most number of recalls at the time. Between 2003 and 2013, Consumers Union reported that DePuy had 277 recalls, followed by Zimmer with 224.
One of the most recent recalls for a DePuy knee implant came in December 2017 when the company recalled its Sigma HP PFJ Cemented Trochlear Implants. Around 7,500 units were recalled after reports of elevated revision rates seen in postmarket surveillance.
The company has come under fire for using the FDA’s 510(k) approval process to get devices like the Attune system on the market. Through the expedited process, a manufacturer does not need to show the device is safe through clinical trials. It only needs to show that the device is “substantially equivalent” to a device that’s already approved on the market.
Along with the hundreds of other knee replacement recalls from DePuy, a component of the Attune system was recalled in 2015.
The manufacturer initiated a Class II Device Recall of Attune Knee Tibial Articulation Surface Instruments.
More than 3,400 units were recalled after a small wire spring called the Balseal in the tibial component of the device was found to be prone to failure.
“If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation,” DePuy said at the time.
No other recalls have been issued for the Attune system, even in light of reports of device failures.
With an estimate of more than 30,000 people in the United States implanted with the Attune system, attorneys around the country expect more lawsuits to be filed against the makers of the knee replacement system.
Those who have been forced to undergo revision surgery after being implanted with the DePuy Attune Knee Replacement System should find an experienced lawyer to discuss whether a lawsuit is the best path forward.
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