A Mississippi woman has filed a knee replacement lawsuit, after she was forced to undergo revision surgery due to the alleged failure of DePuy Synthe’s Attune system.
According to a complaint filed in the U.S. District Court, Southern District of Mississippi, Joyce Rogers received the DePuy Attune Knee Replacement System in February 2015. She underwent revision surgery to remove and replace the system in November 2016, after experiencing severe and persistent pain, discomfort, instability and difficulty ambulating, which was allegedly caused by aseptic loosening of a defective tibial baseplate. (Case No. 3:17-cv-00996-DPJ-FKB)
The lawsuit asserts that beginning in in 2013 and 2014, Johnson & Johnson, DePuy Orthopaedics and other defendants became aware of safety issues with the Attune Knee Replacement System, as concerns were evident in numerous failure reports submitted to the U.S Food & Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE).
“Most related reports concern failures caused by ATTUNE Device design elements which caused loosening and/or debonding at the tibial baseplate cement/implant interthce, These MAUDE reports detail an extremely high incidence of aseptic loosening at the tibial baseplate of the ATTUNE Device resulting in subsequent revision surgeries,” the complaint states.
The lawsuit points out that that more than 470,000 patients have received an Attune Knee since the first device was implanted in November 2011. As of June 2017, the FDA MAUDE database had logged approximately 1,400 reports of Attune knee failures, including approximately 633 reports that had resulted in revision surgeries. By comparison, the competing Persona knee was associated with just 183 reports of device failures, with 64 of these resulting in revision surgeries out of approximately 384, 000 devices implanted.
The DePuy Attune Knee System received clearance from the U.S. Food & Drug Administration (FDA) in 2010 through the 510(k) program. This program allows medical devices to come to market without the benefit of human clinical trials if a manufacturer can show that it is substantially equivalent to a device that was previously cleared through the FDA’s standard premarket approval process.
In June 2015, DePuy announced a knee replacement recall for an Attune Articulation Surface component after finding a spring coil could break off and enter the surgical site without the surgeon’s knowledge. The FDA designated the Attune knee replacement recall a Class II recall, which indicates that a medical device may cause temporary or medically reversible health problems.
A study that appeared in the Journal of Arthroplasty in June 2016 suggested that DePuy Attune Knee Replacements may be associated with a high rate of baseplate loosening and failures due to thicker cobalt-chromium tibial trays that increase the risk of bone loss.