A growing number of individuals continue to come forward against Johnson & Johnson and its DePuy Synthes unit over irreparable harm from Attune Knee Replacement System failure due to substantial defects in the implant’s design.
Donald Sizemore filed one of the most recent Attune Knee Replacement complaints May 31 in the Southern District of Florida. Sizemore received an Attune Knee during his right total knee replacement in March 2014. However, the defective implant failed almost immediately. Among other things, the defective tibial baseplate component began loosening, causing Sizemore severe pain and discomfort. Within two months, Sizemore had to undergo revision surgery to remove and replace the patently defective knee in May 2014.
Sizemore claims that the DePuy Attune Knee System has an unacceptably high rate of premature failure. Consequently, countless people were forced to undergo risky revision surgeries due to the dangerously defective implant. He alleges that the manufacturers concealed these substantial defects in order to maximize profits at the expense of patients' lives. However, rather than admit fault, DePuy attempted to quietly replace the original Attune Fixed Base tibial baseplate, also called a tibial tray. On June 15, 2017, the FDA granted 510(k) clearance for the new component.
“This strategic decision to design and launch a newly designed tibial baseplate is an admission, or at the very least strong evidence, that the original ATTUNE Tibial Tray (baseplate) is defective and prone to failure,” the lawsuit states.
“However, upon information and belief, to date Defendants have not recalled the defective tibial baseplate or informed consumers and surgeons about the dangers of its use.”
In March 2016, the manufacturers sought FDA clearance to market the Attune Revision Knee System. Sizemore asserts this is a response to the growing number of failures and revisions surgeries from the original knee. Consequently, he asserts that this is a direct admission that the manufacturers knew the implant was inherently dangerous.
Attune Knee Failure Studies
Since the Attune Knee hit the market in 2010, at least two studies have suggested the implant is prone to “unusually high” early failure rates. Furthermore, experts assert that these estimates are only a sample of real-world data as they don’t consider unreported events. Consequently, the true Attune Knee failure rate is likely much higher.
In June 2016, the Journal of Arthroplasty published a landmark study indicating that patients with the DePuy Attune Knee were experiencing high rates of baseplate loosening and failures. Researchers attributed these high early failure rates to the device’s thicker cobalt-chromium tibial trays that substantially increase bone loss risks.
A Journal of Knee Surgery study substantiated earlier research findings with a thorough exploration of the Attune Knee failure reports in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. In just three hospitals, researchers identified 15 cases of tibial loosening at the cement-implant interface among Attune Knee patients. Furthermore, these patients began experience serious complications within two years of receiving the defective implant. Researchers found 21 MAUDE reports of this type of tibial loosening in the previous two months alone. There were also “numerous other tibial failure” reports that were not specific as to the responsible mechanism. Researchers further suggested that even this data may be grossly incomplete due to inadequacies associated with the MAUDE system.
“We believe that this complication is underreported due to failure of radiographs to assess loosening. 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,” researchers concluded.