Unfortunately, the DePuy Synthes Attune Knee System appears to be linked to some serious problems. Numerous adverse event reports have been filed with the U.S. Food and Drug Administration (FDA) regarding DePuy Synthes Attune Knee medical complications.(1)
One of the most concerning problems with these implants appears to be “a high rate of debonding of [the] tibial implant–cement interface.”(2) What this means is that loosening is occurring between the cement (bonding agent) and the tibia (shinbone) component of the implant. Typically, in other defective implants, loosening may occur between the implant and bone.
Patients may not detect the loosening right away. Instead, some patients may experience pain for months before seeking answers from their doctor.(3) When doctors take X-rays to see how the DePuy Synthes Attune Knee implant is doing, doctors do not always find anything wrong.
Radiolucent lines, the lines on the X-ray indicating spaces or fracturing around implants, in this case occurring between the cement and the implant, may not be visible. The authors of a 2017 paper discussing several cases of this seemingly signature tibial component loosening, which they remark to constitute “an unusually high rate of early aseptic failures as a failure of implant-cement interface” occurring with the DePuy Synthes Attune Knee noted they “believe that this complication is underreported due to failure of radiographs to assess loosening.”(4)
Patients may continue to experience pain and other medical complications serious enough to necessitate a revision, or corrective, surgery. Only then, during revision surgery, do surgeons discover the implant failed because of loosening that occurred where the tibial component of the implant and cement were supposed to adhere to each other, though the cement was still “strongly adherent to the tibial bone” itself.(5)
In a 2019 study, researchers compared cement adhesion to tibial trays for several different knee designs used in total knee arthroplasties. The researchers discovered that “[n]one of the Attune implants showed evidence of cement adhesion, in contrast with the other designs.” They suggest that this lack of cement attachment, “may be attributable to the differences in design features between the implants.” (6)
DePuy Synthes Attune Knee Implant Problems Reported to FDA
As of August 2017, according to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, hundreds of adverse event reports regarding the DePuy Synthes Attune Knee implant exist. What is particularly disturbing is that many of them discuss “loosening of the tibial component at the cement to implant interface.”(7) (8) (9) This loosening has led to many revision surgeries to correct the defect.
Researchers have “noted a large number of revision cases in a short period of time in patients who received” the DePuy Synthes Attune Knee implant. When examining MAUDE database reports, they found “many reports have been filed in [the] MAUDE database concerning tibial loosening at the implant-cement interface” noting there “appears to be a similarity in the mechanism of failure.”(10)
Loosening, pain, and revision surgeries are significant DePuy Synthes Attune Knee implant complications. Loosening of a knee implant, or any of its components, is extremely serious: in the cases of tibial loosening of the DePuy Synthes Attune Knee reported in the FDA’s MAUDE database, patients typically required a revision surgery to correct the situation.(11) (12) (13)
Revision surgeries are not something to take lightly. They are not simply do-over primary surgeries.
The “requirement for revision surgery…increases the risk for re-revision surgery.”(14) Revision surgeries are also “associated with considerable expense, morbidity, and inferior clinical outcomes compared to primary surgical procedures.”(15)
In essence, “the success rate for revision surgery is usually lower than that for the original surgery because the bone is weaker.”(16)
We would feel privileged to assist you. For a free consultation and more information about your legal options, please contact us today.
DePuy Knee Lawsuits
Weitz & Luxenberg is now accepting clients who received a DePuy Synthes Attune total knee replacement implant with a fixed-bearing tibial component who needed to undergo a revision, or corrective, surgery due to tibial loosening. Or, if you have not yet undergone a revision surgery but received a DePuy Synthes Attune Knee implant and are experiencing medical complications resulting from the loosening of its parts, we encourage you to contact us.
We are particularly concerned if you have received a DePuy Synthes Attune posterior-stabilized fixed-bearing knee implant or DePuy Synthes Attune cruciate-retaining fixed-bearing knee prosthetic. Having one of these types of DePuy Synthes Attune Knees implanted may result in potentially debilitating complications due to premature loosening of the tibial component.
If you are experiencing medical complications related to a knee implant, we encourage you to check with your doctor to see if you received a DePuy Synthes Attune Knee implant or contact us right away. Depending on your circumstances and the implant model you received, you may be eligible to pursue legal compensation.
Our Weitz & Luxenberg attorneys, who have worked on other defective medical devices lawsuits, can help you evaluate your legal options. For a free consultation, we invite you to call Weitz & Luxenberg at (855) 807-7752. One of our representatives will contact you shortly.
Weitz & Luxenberg Can Help You
For more than 30 years, Weitz & Luxenberg has taken on large-scale medical manufacturers, such as DePuy Orthopaedics. Our attorneys working in Weitz & Luxenberg’s Defective Drugs and Medical Devices litigation unit are specifically trained to handle complex medical device lawsuits.
In fact, in recent years, Weitz & Luxenberg attorneys have led the fight against DePuy regarding certain models of its hip implants. Our attorneys have also been instrumental in reaching settlements with DePuy Orthopaedics and other large-scale medical manufacturers when we brought lawsuits against them for their defective products.
People harmed by defective DePuy hip implants have been receiving their compensation payments from a $2.5 billion settlement. These patients experienced debilitating medical complications following failed hip implants.
We are privileged that Ellen Relkin, one of our most seasoned attorneys, co-led this multidistrict litigation. With her at the helm of the negotiating team, thousands of people are finally seeing a just end to this litigation process.
DePuy Knee Implant Complications
Possible DePuy knee implant complications for the Attune Knee for which you could receive compensation include:
- Revision, or corrective, surgery due to tibial (shinbone) component loosening or debonding of cement from the implant
- Limited range of motion
DePuy Knee Warnings
When DePuy notified the FDA it was introducing the Attune Knee implant to the market, the company indicated, “Total knee replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.”(17)
What is unfortunate is that adverse reports and literature regarding the DePuy Synthes Attune Knee suggest many patients have not been able to rely on this model for increased mobility and reduced pain after all. Instead, FDA adverse reports reveal troubling complications regarding the device’s tibial component loosening at the implant-cement interface.(18) (19) (20)
Any medical complications following total knee replacement surgery are unwelcome, but some require revision surgery. Loosening that occurs between the tibial implant component and the cement, or bonding agent, is one such significant problem.
Weitz & Luxenberg Is Here for You
Weitz & Luxenberg is a national firm that, for more than 30 years, has committed itself to helping people who have been harmed by defective medical devices. The team at Weitz & Luxenberg believes that people should be able to depend on the medical products available to them.
If you purchase a medical device such as a cane and it turns out to be defective, you can simply exchange the product, or return it and receive a refund. This annoyance is one problem you can fix rather easily.
However, if you receive a defective knee implant, resolving the situation is far from easy. The cost to you financially, physically, and emotionally is incalculable.
You should not have to bear the brunt of issues caused by a medical manufacturer who took shortcuts to introduce its defective products to market. The manufacturer of the defective device should step up and take full responsibility for its actions. You should be fully compensated for the pain, suffering, and disruption you have experienced. Weitz & Luxenberg is here for you when medical manufacturers do not act responsibly.
We have a history of winning because we are determined to hold irresponsible manufacturers accountable. Whether you have been harmed by a medical device or dangerous medication, if you suffered personal injury through the negligent actions of a large company, our attorneys are here for you.
We have won more than $17 billion in verdicts and settlements for our clients.