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What is the DePuy Attune Knee System?

The DePuy Attune Knee System is a total knee replacement implant, meant to improve stability and motion in patients who suffer from arthritis of the knee or a weakened knee joint. The manufacturer, DePuy Synthes, is a subsidiary of Johnson & Johnson.Their device was approved in the United States by the Food and Drug Administration in December, 2010 under the agency’s 510(k) clearance process.

Devices which have been approved through this process are not required to have conducted clinical trials, nor do they require any evidence of safety before being approved and distributed for implantation. This allows medical devices to be made available for use in treatment faster, given the less-vigorous approval process. However, this expedited process increases the riskthat a faulty device will be distributed without proper evaluation.

The Depuy Attune knee implant was built with several objectives in mind, including materials and components intended to improve range of motion and stability of the knee, while also preventing stiffness. The metal parts within this device are created from a Cobalt-Chromium-Molybdenum alloy. The plastic parts within the device are made from the company’s own polyethylene formula.

The implant surgery typically takes approximately two hours for surgeons to complete. Surgeons will remove the damaged bone, replace it with the Attune knee implant, and then use cement to keep the device securely in place.

The hope was that this device would relieve a patient’s pain, and help reduce arthritic pain if non-surgical solutions were no longer sufficient. While this was the hope, thousands of patients have reported an array of complications. The most common complaint is the loosening of the implant, with the adhesive bonding failing to secure the impant to the existing bone surrounding the knee.

As the pain accumulates due to these failures, so do the medical expenses associated with the revision surgery and any physical therapy which is required afterwards. These additional cost burdens place recipients and their families in financial jeopardy. Medical devices are meant to improve the quality of life of patients– not increase their financial burdens, overall stresses and daily pain.

What You Need to Know About the DePuy Attune Knee Implant Failures

If you have experienced pain or complications from the DePuy Attune Knee Implant, know that you are not alone. As mentioned, there are thousands of patients who have been affected, and this means there is considerable evidence upon which to build a case with the goal of securing the compensation you deserve for your pain and suffering caused by this faulty product.

Current evidence includes:

• The number of Canadian knee replacements has increased by 17 per cent in the last five years. The total number of surgeries performed annually is 70,000. Typically, patients who receive a total knee replacement can expect the implanted joint to last about 20 years. The DePuy has been failing at a much faster rate for many patients, most within less than two years.
• Multiple studies have found that the device’s adhesion to the patient’s bones is one of the bigger failures with the DePuy Attune Knee Implant system. The bonding cement has been found to fail to hold the components of the device to the tibia. Due to this failure, the implant loosens and even separates from the patient’s natural bone, resulting in the device failing entirely. A 2017 study published in the Journal of Knee Surgery, in particular, found a high rate of early failure in knee replacement surgeries, related to the adhesive and tibia’s secure connection to one another.
• To date, nine orthopedic surgeons examined reports submitted to the FDA’s MAUDE database on device failure,s and have found a total of 232 reports to involve the Attune.
• In May of 2018, DePuy Synthes released a study to show that their system improved the quality of life in patients who had undergone replacement therapy with the implanted device. However, results from the study showed that one in five patients who received the device were unsatisfied following surgery, and even experienced zero improvements. This data falls well below the national average in Canada for knee replacement surgeries.
• Between 2002 and 2013, DePuy Synthes recalled a total of 277 knee replacements and additional components, due to problems such as implant loosening and premature failure. This was a Class I device recall, meaning that the product is linked to serious or even fatal adverse health consequences.
• Additionally, in June of 2015, a Class II device recall was issued for the Attune Knee Tibial Articulation Surface Instruments. Surgeons will use these instruments to implant Attune devices during surgery, and around 3,400 defective surgical instruments were recalled due recurring findings by hospital staff that a small wire spring coil, called a Balseal, could break off and fall into the surgical site during surgery. There were incidents of this wire spring coil being left inside the patient’s body without surgical staff realizing this had happened.
• Despite all of these issues, DePuy Synthes does not warrant its Attune knee replacement products. This means that revision surgeries have been the only way for patients to correct any defective knee implant.

Am I a Victim of Device Failure?

If you or a loved one have experinced any of the following, the reason may be a malfunctioning or defective DePuy Attune Knee Implant System:

• Pain
• Instability
• Swelling/abnormal warmth
• Stiffness
• Limited mobility

Resources

• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101433
• https://www.cihi.ca/en/hip-and-knee-replacements-in-canada-cjrr-annual-report
• https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0037-1603756
• https://www.depuysynthes.com/about/news-press/qs/attune-knee-system-linked-to-improvements-in-patient-quality-of-life-and-reduced-length-of-hospital-stay
• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137734