A Kentucky man has filed a new knee replacement lawsuit against DePuy Synthes, after he required revision of an Attune Knee due to an allegedly defective tibial baseplate.
According to a complaint filed in the U.S. District Court, Eastern District of Kentucky on February 1st, Robert Long underwent right total knee replacement surgery in January 2015. The procedure involved DePuy Attune devices, including a fixed tibial insert and fixed tibial baseplate. (Case No. 6:18-cv-00032-GFVT)
Within two years of his surgery, Long began to experience persistent pain, discomfort, instability and difficulty walking. Radiographs indicated aseptic loosening of the tibial baseplate.
Though Long underwent revision surgery in February 2017, his complaint indicates that he continues to suffer ongoing injuries due to his Attune Knee complications.
“All of the injuries and complications suffered by Mr. Long were caused by the defective design, warnings, construction, and unreasonably dangerous character of the Attune system that was implanted in him,” the lawsuit states. “Had Defendants not concealed the known defects, the early failure rate, the known complications, and the unreasonable risks associated with the use of the Attune system, Mr. Long would not have consented to the Attune system being used in his total knee arthroplasty.”
The DePuy Attune Knee System was brought to market in 2010 via the U.S. Food & Drug Administration’s (FDA) the 510(k)-clearance program. A 510(k) clearance allows manufacturers to sell a medical device without first subjecting it to human clinical trials, so long as it can demonstrate that the new product is substantially equivalent to a device that was previously cleared through the FDA’s standard – and more stringent – premarket approval process.
A DePuy Attune Knee recall was announced in June 2015 for an Articulation Surface component because of a potentially defective spring coil. According to the FDA, the spring coil could break off and enter the surgical site without the surgeon’s knowledge. The agency categorized the recall as Class II, which indicates that the component could 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.
Additional research published in the Journal of Knee Surgery identified 15 cases of tibial loosening at the cement-implant interface among patients who had undergone revision of an Attune Knee at three hospitals. The authors of the study also identified 21 similar reports that had been logged with the FDA’s adverse event database within a two-month time period, along with numerous reports of other tibial failures in which the mechanism for failure was not specified.
“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,” the study authors wrote.
A Letter to the Editor published in the same journal suggested that Attune Knee problems required additional investigation and possibly a registry study to better understand the scope of the issues.