More than two-dozen plaintiffs have filed suit in Los Angeles Superior Court over allegedly defective knee replacement devices marketed by B. Braun’s Aesculap Implant Systems subsidiary.
The complaint was filed in October, nearly a month after DePuy Synths was named in a knee replacement lawsuit involving the Attune Knee System, which recent research suggests could be associated with high rates of tibial loosening.
As was the case with DePuy Attune Knee Replacements, Aesculap’s advanced surface ceramic-coated knees were cleared through the U.S. Food & Drug Administration’s (FDA) 510(k) program, which does not require a new device to undergo human clinical trials if a manufacturer can demonstrate that the product is “substantially equivalent” to a device that was previously approved by the agency.
While marketing materials touted Aesculap’s advanced surface knees as superior to standard bare metal knees, the 25 plaintiffs suing the company claim that the ceramic joints are defective and don’t properly bond with the cement used to attach the devices to a patient’s bones.
While knee replacement removal usually requires a saw to cut through the bonding cement, plaintiffs allege that in cases involving Aesculap’s ceramic coated knees, “the implant components were easily removed by hand, using just two fingers, or after a single mallet strike.”
While numerous physicians reported these problems to B. Braun and Aesculap, the companies blamed the knee replacement failures on a variety of factors, including the brand of bone cement or the surgeons’ cementing technique. However, instructions for use included with Aesculap’s ceramic coated knees did not include specific guidance on the type of cement or technique that should be used when implanting the devices.
Plaintiffs further charge that B. Braun has concealed these problems from the FDA, and has even terminated a clinical trial in bad faith after a participating physician noticed the bond between an Aesculap knee implant and cement had failed.
In September, one of the first DePuy Attune Knee lawsuits was filed in U.S. District Court, Middle District of Louisiana, on behalf of a patient who was forced to undergo revision surgery within a few years of his initial knee replacement procedure due to tibial loosening. The lawsuit asserts that the loosening was the result of bond failure between the tibial baseplate and the implant-cement surface.
A month before the suit was filed, a study published in the the Journal of Knee Surgery warned that the FDA had received an unusual number of Attune Knee complaints linked to tibial loosening and failures.
A study that appeared in the Journal of Arthroplasty in June 2016 suggested that 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.
More than 470,000 patients have received an Attune Knee since the first device was implanted in November 2011. However, Attune Knee lawsuits note that the FDA’s MAUDE database had received roughly 1,400 reports of failures as of July 2017. Approximately 633 of these cases resulted in revision surgeries.