A law firm based in Alabama has filed the first lawsuit involving the DePuy Synthes Attune Knee System over claims that the knee replacement system experiences premature failure, resulting in the need for revision surgery.
The lawsuit, filed on Sept. 13 in the Circuit Court of Tuscaloosa County by Cunningham Bounds LLC, alleges that Johnson & Johnson subsidiary DePuy Synthes has made a device that fails to do what it claims.
The system was first introduced in 2010 as a way to improve patient outcomes for total knee arthroplasty while increasing the longevity of the knee. Thousands of patients have been implanted with the Attune Knee System.
Study Finds High Rate of Failure in DePuy Knee System
The first DePuy Synthes Attune Knee System lawsuit comes just weeks after a new study revealed that the total knee arthroplasty system is experiencing an unusually high rate of early failures.
Nine prominent orthopedic surgeons published a study in the Journal of Knee Surgery earlier this month saying they had encountered a “high rate of debonding of tibial implant–cement interface” in the DePuy knee replacement system. This means the glue keeping the system held together did not hold as it should, potentially causing instability.
The surgeons looked at reports submitted to the U.S. Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database. The FDA houses the hundred thousand medical device reports it receives from manufacturers and device user facilities in the MAUDE database.
According to the study, the MAUDE database has a total of 232 reports involving Attune.
The authors of the study compiled the clinical, radiographic, and intraoperative findings of patients who received the knee replacement system and had to undergo revision surgery.
By reviewing three hospital databases for patients who had experienced tibial loosening at the implant-cement surface and needed revision surgery, the authors of the study found 15 cases. Those patients had a mean age of 61 years.
“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,” the authors wrote. “Intraoperative findings demonstrated gross loosening of the tibial component at the implant–cement interface.”
In the last two months alone, the authors found 21 reports of tibial loosening at the implant-cement interface in the MAUDE database. They also noted that several other tibial failures were reported but that the “mechanisms of failures were not specified.”
“We believe that this complication is underreported due to failure of radiographs to assess loosening,” the authors wrote. “In addition, MAUDE database reporting is not consistent and competing companies cannot provide data on the revised components. In patients who have negative workup for a painful joint, one must consider the diagnosis of debonding.”
Whether the early failures in the Attune Knee System are frequent or rare events remains unclear. Dr. Michael Mont of the Cleveland Clinic wrote a response to the study asking for a deeper investigation into the issue.
“When one looks at a case series, we really do not know the denominator, and this certainly could have been a series of cases out of more than 100,000 done, which would make this a rare event,” Mont wrote. “Therefore, simply publishing cases are not evidence-based medicine, as we do not know how many of these were implanted.”
The study published in the Journal of Knee Surgery was specifically cited in the lawsuit against DePuy Synthes over the Attune Knee System.
DePuy’s Attune Knee System Recalled in 2015
This isn’t the first time DePuy has come under fire for its Attune Knee System.
In 2015, DePuy initiated a Class II recall of the Attune Knee Tibial Articulation Surface Instruments. More than 3,400 units were recalled after a small wire spring coil called the Balseal was found to be prone to damage.
“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 warned in the FDA announcement.
Like many medical device companies, DePuy offers no warranty on its defective knee replacement products. The only way to correct the issue is often revision surgery.
According to Consumer Reports, 10 percent of the knee replacements done each year are revisions with product defects being a common reason. The American Academy of Orthopedic Surgeons says that “total knee replacement is one of the most successful procedures in all of medicine” but revision surgery “is a longer, more complex procedure that requires extensive planning, and specialized implants and tools to achieve a good result.”
In recent years, the non-profit organization Consumers Union has urged makers like DePuy Synthes to provide patients with a warranty on medical hip and knee replacement devices to cover the cost of revision surgery.
DePuy Has Long History with Recalls and Device Failures
While the DePuy Synthes Attune Knee System has yet to be recalled over the possible early failures, DePuy and other orthopedic companies are no strangers to recalls.
Between 2003 and 2013, more than 700 devices or components of knee implants made by six companies were recalled. According to Consumers Union, DePuy had the largest number of recalls during that period with 277.
The recalls from DePuy dealt with sizing issues, mislabeled components, fracturing during normal activities, assembly difficulties and more.
According to the Agency for Healthcare Research and Quality, more than 600,000 knee replacements are performed every year with the number of total knee replacements expected to grow to 3.5 million a year by 2030.