The DePuy Attune Knee System is one of the most popular artificial knee replacement systems currently on the market. However, since its approval in 2010, many DePuy Attune Knee Replacement pateints have reported problems with the device, some of which have resulted in the need for risky revision and reconstructive surgery.
Atttune knee devices are manufactured and marketed by Johnson & Johnson’s DePuy Orthopaedics subsidiary. The total knee replacement system was cleared for sale via the U.S. Food & Drug Administration’s (FDA) 510(K) program, which does not require a device to undergo human clinical trials if a manufacturer can show that the product is substantially equivalent to another device that has already been approved by the FDA.
The 510(K) program is highly controversial. In 2011, a paper published in the Archives of Internal Medicine reported that nearly three-quarters of the medical devices recalled from 2005-2009 had been granted FDA clearance through the 510(K) program.
That same year, the Institute of Medicine issued a report highly critical of the 510(K) program, after concluding that it fails to ensure that medical devices are safe before they come to market. The organization recommended that the FDA eliminate the program entirely and replace it with an “integrated pre-market and post-market regulatory framework.”
In marketing materials for the Attune Knee System, DePuy touts its use of “patented technologies” that are purported to improve range of motion and give patients “the confidence of a stable knee replacement.”
Features of the Attune Knee Replacement System include:
The first Attune Knee Replacement System was implanted in November 2011. To date, more than 470,000 patients have received a DePuy Attune Knee.
A study recently published in the Journal of Knee Surgery by nine prominent orthopedic surgeons suggested that the DePuy Attune Knee Replacement System had been associated with an “unusually high” rate of early failure related to its tibial components.
The authors of the study identified 232 reports of Attune Knee failure in the FDA’s Manufacturer and User Facility Device Experience database.
An analysis of the MAUDE incidents uncovered 21 reports of tibial loosening at the implant-cement in the past 2 months alone. “Numerous other tibial failures” were also reported without the mechanism for failure specified.
The surgeons also searched three hospital databases, identifying 15 cases of tibial loosening at the implant-cement interface.
“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,” they wrote. “Intraoperative findings demonstrated gross
“We believe that this complication is underreported due to failure of radiographs to assess loosening,” they concluded. “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.”
One of the first DePuy Attune lawsuits was filed in September 2017 in the U.S. District Court, Eastern District of Louisiana. (Case No. 3:17-cv-00682-SDD-RLB)
Among other things, the complaint noted that, as of June 2017, that the FDA’s MAUDE database had received roughly 1,400 reports of Attune Knee failures, of which approximately 633 of resulted in revision surgeries.
“By comparison, for the Persona knee replacement system, manufactured by Zimmer, approximately 384,000 devices have been implanted, and the MAUDE database has a collection of only 183 reports of device failures with 64 of these resulting in revision surgeries.”
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