Dive Brief:
- A lawsuit filed against Johnson & Johnson subsidiary DePuy Orthopaedics, accuses the company of downplaying the risks of its Attune knee replacement system.
- The sole plaintiff, Dwight Petty, had a total knee replacement surgery with the Attune device in 2017, and afterwards, he claims in the suit, started experiencing “persistent pain.” During a revision surgery in 2020, it was discovered that the tibial portion of the implant had loosened.
- The April 17 complaint claims that the Attune system has “significantly higher failure rates than other replacement knees due to the debonding of the tibial baseplate,” and that the company never recalled the baseplate or informed doctors and patients about the risks.
Dive Insight:
DePuy started selling its Attune knee replacements in 2013, marketing the device as fitting a group of patients that hope to maintain an active lifestyle. However, the attachment between the artificial knee and the existing bone could loosen, causing patients to need another surgery. This mechanical loosening happened at an “unprecedented rate” in patients implanted with the Attune device, the lawsuit claims, citing studies published in 2017, including one that found an “unusually high” rate of early failure for the device’s tibial components.
Attune was never recalled for the baseplate problem, but in 2016, J&J requested FDA approval for a version of the device with a new tibial baseplate.
The lawsuit, filed in federal court in North Carolina, claims that the company “downplayed the health risks associated with the ATTUNE Device through promotional literature and communications with orthopedic surgeons.”
Petty is seeking a jury trial and $75,000 in damages. Previous lawsuits have been filed related to the Attune device, including cases filed in 2017 and 2019.
The lawsuit claims that as of June 2017, the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database included approximately 1,400 reports of failures for the Attune knee, noting that about 633 of the reported incidents resulted in revision surgeries. For the Persona knee replacement system, made by Zimmer Biomet, of 384,000 implanted devices the MAUDE database had 183 reports of device failures, with 64 resulting in revision surgeries as of June 2017, according to the lawsuit.
“We are confident that the evidence will show that the company acted appropriately and responsibly in the design and testing of the ATTUNE Knee System. We are committed to the defense of the allegations in this lawsuit,” a DePuy Synthes spokesperson wrote in an email.
The case is Petty v. DePuy Orthopaedics Inc. et al in U.S. District Court for the Western District of North Carolina.
Updated to include comment from DePuy Synthes
