DePuy Faces Yet Another Lawsuit Concerning its Attune Knee Replacement System

Jackson, MIWhenever an individual files a defective knee implant lawsuit, the focus is normally – and correctly – on the failed component due to an alleged design, or manufacturing defect. But a companion issue just as devastating as the failure of the implant is, for the patient, a requirement for revision surgery to eradicate the problematic implant and replace it with another one. Revision surgery is usually, a more complex procedure.

Revision surgery often closely follows the first. In the foregoing case, a plaintiff in a DePuy Attune lawsuit faced revision surgery about two years after the first procedure. This would require the patient to repeat the process of surgery, recovery, healing and rehabilitation together with the related impacts to lifestyle and livelihood – for some, involving more time off work – not long after returning to normal from the initial procedure.

Joyce Rogers is the plaintiff in a DePuy implant lawsuit recently filed in US District Court for the Southern District of Mississippi. According to Court documents Rogers underwent knee replacement surgery in February 2015. Surgeons deployed the DePuy Attune, a knee replacement system approved by the US Food and Drug Administration (FDA) in 2010 and heavily promoted to the healthcare community. Less than two years following initial surgery, Rogers’ DePuy Attune artificial knee failed in November 2016 requiring a revision procedure.

Later-generation implants appear to fail more frequently than older devices

Artificial knees and hips are historically designed to last for 15 years, providing good service under normal conditions. More modern, later-generation devices with updated designs and materials were thought to last even longer.

However, this has not been the case for many.

“Recipients of the Attune Devices have been required to undergo revision surgeries well before the estimated life expectancy of the Attune Devices and at a much higher rate than should reasonably be expected for devices of this kind,” Rogers’ lawsuit states. “Despite knowledge that the Attune Devices were defective and resulted in the aforementioned failures and accompanying complications. Defendants continue to aggressively market and sell the defective Attune Devices, all the while maintaining that they are safe and effective for use in total knee replacement.”

Three years after the DePuy Attune artificial knee replacement system was approved by the FDA, the device was already in wide use by 2013. However problems began to appear. The FDA was reported to have in its Adverse Reports database about 1,400 examples of DePuy Attune failure by June of last year, with at least 633 of those reports encompassing the need for implant replacement through revision surgery.

Such failures were reflected in a report that appeared in the Journal of Knee Surgery, in which study authors opined that the system initially showed “good early outcomes in a prospective study after 2-year follow-up.” (Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant–Cement Interface: Peter M. Bonutti, Anton Khlopas, Morad Chughtai, Connor Cole, Chukwuweike U. Gwam, Steven F. Harwin, Brent Whited, Didi E. Omiyi, Joshua E. Drumm). “However, in our experience of three community hospital centers, we have encountered an unusually high rate of early aseptic failures as a result of failure of implant–cement interface.

“In addition, multiple reports have been filed in MAUDE database (Manufacturer and User Facility Device Experience) concerning tibial loosening at the implant–cement interface. After carefully examining the implant design, we have proposed several possible reasons for this early aseptic loosening, which include increased constraint, reduced cement pockets, reduced keel rotational stabilizers, and reduced surface roughness of the tibial component when compared with the previous generation implant. Although we report on only 15 cases, we believe that this complication is markedly underreported due to failure of radiographs to accurately assess loosening.”

Plaintiff asserts manufacturer knew about problems, or should have…

In her DePuy Attune knee replacement lawsuit, Rogers asserts that DePuy and co-defendant Johnson & Johnson either knew, or should have known about problems with its replacement knee device, but proceeded to put the plaintiff and others at risk while continuing to market the device.

The DePuy Attune lawsuit is Joyce Rogers v. DePuy Synthes Sales, Inc. et al, Case No. 3:17-cv-996-DPJ-FKB, filed December 11, 2017 in the US District Court for the Southern District of Mississippi, Northern Division.