Though hundreds of patients are alleged to have experienced early failure of DePuy Orthopaedic’s Attune Knee System, only one component has ever been subject to a recall. However, the absence of a full DePuy Attune Knee Replacement recall in no way prevents individuals from taking legal action if they experienced complications that may be associated with the premature failure of this total knee replacement system.
Our DePuy Attune Knee Replacement lawyers are offering free, no-obligation legal reviews to individuals who suffered debilitating complications and/or underwent knee revision surgery due to premature failure of the Attune Knee System.
To learn if you might be eligible to file a DePuy Attune Knee lawsuit, please call (888) 994-5118.
The DePuy Attune Knee Replacement System obtained regulatory clearance in 2010, through the U.S. Food & Drug Administration’s (FDA) 510(k) program. Because DePuy could demonstrate that the Attune Knee System was substantially equivalent to previously approved total knee replacement systems, the implants did not undergo human clinical trials before coming to market.
The DePuy Attune Knee System has become one of the most popular options for individuals undergoing total knee replacement. More than 470,000 patients have received an Attune Knee since the first device was implanted in November 2011.
DePuy promises that the Attune Knee System will provide patients with increased stability and a better range of motion. However, a recent study conducted by nine prominent orthopedic surgeons suggests that the Attune Knee may be associated with an unexpectedly high rate of early failures, often due to tibial loosening.
The authors of the study sought to identify Attune Knee System patients who had revision surgery on a total knee arthroplasty for tibial loosening at the cement-implant interface. An analysis of three hospital databases identified 15 such cases. All of the patients knees were removed within two years of their initial surgery and all were found to have loose components due to a lack of cement bonding the tibial baseplate to the bone.
The authors of the study were also able to identify 21 reports of tibial loosening at the implant-cement interface in the FDA’s Manufacturer and User Facility Device Experience database (MAUDE).
“Tibial component loosening is a rare complication of cemented TKA at short-term follow-up. Several possible reasons include increased constraint, reduced cement pockets, and reduced keel rotational stabilizers. The tibial component, which has greater torsional loads, has lower surface roughness than femoral component,” the study authors wrote. “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.”
Since the publication of this study, several Attune Knee Replacement lawsuits have been filed against DePuy and its parent company, Johnson & Johnson, on behalf of patients who allegedly suffered premature failure of their implants.
Plaintiffs who have filed these case claim that the defendants knew about the Attune Knee’s alleged defects and high early failure rate, yet failed to share this information with doctors who used the devices.
Among other things, the complaints note that the FDA’s MAUDE database had received roughly 1,400 reports of Attune Knee failures as of July 2017. Approximately 633 of these cases resulted in revision surgeries.
“By comparison, for the Persona knee replacement system, manufactured by Zimmer, approximately 384,000 devices have been implanted, and the MAUDE database has a collection of only 183 reports of device failures with 64 of these resulting in revision surgeries,” the lawsuits state
Currently, there is not an active DePuy Attune Knee Replacement recall. However, a Class II medical device recall was conducted in 2015 for one component of the system, the Attune Articulation Surface, after it was it was determined that a spring coil could break off and enter the surgical site without the surgeon’s knowledge.
A Class II recall indicates that a medical device may cause temporary or medically reversible health problems.
You may be eligible to file a DePuy Attune Knee lawsuit if you suffered failure of your knee implant within just a year or two of your initial knee replacement surgery.
Complications and symptoms associated with premature knee replacement failure include:
To learn more about filing a DePuy Attune lawsuit, please call (888) 994-5118 to obtain your free legal consult today.
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