After only one or two years since receiving DePuy Attune knee implants, thousands of patients have suffered very serious complications. Orthopedic surgeons have been questioning the quality of the device due to this high failure rate and several patients have since filed lawsuits against DePuy for making a defective product.
If you or a loved one has experienced pain, other complications or required revision surgery after receiving the DePuy ATTUNE Total Knee Arthroplasty system (TKA), the class action lawyers at Rastin Law we are prepared to help you recover the compensation you need and deserve. Our Knee implant injury attorneys offer a complimentary review of your claim and should we determine that you have a case, there are no upfront costs for our services unless we help you obtain fair compensation.
What is the DePuy Attune Knee System?
The DePuy Attune Knee System is a total knee replacement implant designed to improve stability and motion in those suffering from arthritis of the knee or a weakened knee joint. The implant is manufactured by DePuy Synthes, a subsidiary of Johnson & Johnson, and was approved in the United States by the FDA in December of 2010 under the agency’s 510(k) clearance process. Devices approved under this process do not require clinical trails to be conducted or any evidence of safety before being approved. This allows medical devices to become available on the market faster under a less-vigorous approval process.
The Attune knee implant is also comprised of several components manufactured to improve range of motion and stability of the knee and prevent stiffness. These metal parts are made from a Cobalt-Chromium-Molybdenum alloy and plastic parts made from the company’s own polyethylene formula.
The knee replacement surgery to implant this device lasts approximately two hours. Surgeons remove the damaged bone, replace it with the Attune knee implant and use cement to keep the device in place.
Patients hope the device will relieve their pain and help improve their quality of life after non-surgical treatments have stopped working. Unfortunately, thousands of patients reported numerous complications, most notably the loosening of the implant and adhesive bonding failures to the existing bone surrounding the knee.
Medical expenses associated with the revision surgery and post-surgery physical therapy can accummulate rapidly, putting recipients and their families at a significant financial disadvantage. Our lawyers have helped many injury victims and we know how quickly this can happen. You need an experienced legal team with a track record of success to help build a strong case and pursue fair compensation through a DePuy Attune Knee Implant lawsuit.
Am I Entitled to File a Lawsuit?
A growing number of lawsuits have been filed against DePuy Synthes by patients who claim the Attune knee implant prematurely failed. Following surgery, patients have reported serious adverse health effects such as looseness, instability, abnormal warmth, unexplained swelling and severe pain. Consequently, many patients have required revision surgery to repair or replace the implant.
The lawsuits these patients have filed make various allegations against the company, including:
- Failing to adequately warn about the potential side effects linked with the knee replacement system
- Manufacturing a device with a design defect that had a high rate of premature failure and loosening
- Failing to warn surgeons and patients of the serious risks of tibial loosening and adhesive failure
- Actively mispresenting Attune’s reliability and safety when DePuy Synthes knew or should have known of the high risk of the tibial component part loosening and causing instability of the knee
Rastin Law is here to represent you in cases involving failing adhesive in knee replacements. If you or a loved one has suffered complications caused by the Attune knee implant, you may be entitled to file a Depuy Attune Knee Implant lawsuit. Contact us today so we can determine whether you have the right to take legal action, by conducting a thorough investigation to answer the following questions:
- Was the Attune knee implant defective?
- Was the Attune knee implant inherently dangerous?
- Did DePuy Synthes know the risks and not warn people?
- Was negligence involved in you needing knee replacement revision surgery?
- Did you suffer additional pain and discomfort as a result of receiving the Attune knee implant?
If you file a DePuy Attune knee implant lawsuit, you could recover compensation for any medical expenses you have incurred and will incur in the future, lost wages for missing work to recover from your knee replacement surgery, pain and suffering, and possibly other damages.
The experienced personal injury lawyers at Rastin Law will guide you throughout every step of the legal process, so you can focus on your health and recovery. We have been trusted by many injury victims to represent them in their time of need and we get results. Our trusted lawyers are ready to help you get the compensation you deserve and and hold these large corporations accountable.
Alarming Statistics on Complications and Device Failures
Total knee arthroplasty (TKA) is one of the most common joint replacement surgeries in Canada. The number of Canadians having knee replacements has increased by 17 percent over the last five years, with 70,000 surgeries now performed annually. For the majority of people who have total knee replacement, the new joint should last about 20 years, but the DePuy Attune Knee implant has failed much faster for numerous patients, in less than two years. The Canadian Institute for Health Information tracks the rising number of early revision surgeries that are being done on Canadians who have had joint replacement surgeries.
In Canada, more than 9,000 patients had knee or hip revision surgeries performed in 2018, representing seven per cent of all joint replacement surgeries in the country. Revision surgery is generally more invasive and painful and can also bring its own complications, such as infections and mounting medical expenses. It costs nearly 80 per cent more (approximately $17,000) to do the revision surgery than it does to do the joint replacement.
Studies on Attune Knee Implant Failure
Researchers in multiple studies have found that device adhesion to the bone is one of the biggest problems with the DePuy Attune Knee Implant system. The cement used to adhere to the natural bone and hold the implant in place fails to bond the components to the tibia, the larger bone in the lower leg. This has caused the implant to loosen and break away from the natural bone. When this happens the device has failed.
A 2017 study published in the Journal of Knee Surgery found an unusually high rate of early failure related to the implant’s tibial components. Signs of premature implant failure include pain, instability, swelling, stiffness, and limited mobility. Nine orthopedic surgeons examined several reports submitted to the FDA’s MAUDE database on device failures and found a total of 232 reports involving Attune.
The surgeons also examined three hospital databases related to Attune devices. They encountered a high rate of tibial loosening at the implant-cement interface, which can destabilize or dislocate the entire knee implant. In 15 cases, patients who experienced tibial loosening after the implant needed revision surgery.
In May of 2018, DePuy Synthes released a study attempting to show the success of their implant system, claiming that it has helped improve the quality of life for many patients who have undergone the knee replacement surgery. The issue, however, is that the study also reveals that one out of every five patients who received the DePuy Attune Knee implant expressed dissatisfaction after the surgery or experienced no improvement at all. This data is well below the national average for knee replacement surgery in Canada.
If you have suffered complications after receiving the DePuy Attune knee implant, you may be able to take legal action and obtain compensation to help cover your medical costs.
DePuy Synthes’ History of Knee Implant Recalls
Despite reports of high failure rates, there has not been an official recall of the DePuy Attune Knee System. Although between 2002 and 2013, the company did recall a total of 277 knee replacements and components due to problems such as implant loosening and premature failure. This included four Class I device recalls, which meant the product is linked to serious or fatal adverse health consequences.
In June of 2015, a Class II device recall was issued of the Attune Knee Tibial Articulation Surface Instruments. Surgeons use these instruments to implant Attune devices during surgery. About 3,400 defective surgical instruments were recalled due to findings that a small wire spring coil called a Balseal could break off and fall into the surgical site and be left inside the patient’s body without being noticed by the surgical staff.
Similar to other manufacturers, DePuy Synthes does not offer warranties on its Attune knee replacement products, making revision surgeries the only way for patients to correct a defective knee implant.