Attune Knee and the FDA Approval Process

The Attune Knee System has been implanted into thousands of patients and is one of the most commonly used knee implant devices on the market. However, patients who have received the knee implant have complained of device malfunctions and failures, and many are speaking with an Attune knee implant attorney to learn more about their rights and the legal options available to them, including whether they are eligible for compensation for their injuries.

Device Recalls and the Role of the 510(k) Process

Even though the Attune Knee System is a popular and commonly used device, it has a history of being recalled for a wide variety of issues. After being approved for the market in 2010, the first recall was issued in 2012, followed by another in 2014, then again in 2015 and 2018. These recalls were issued over problems such as packaging issues, pin bushing overloads, burs on extraction thread holes, and extraction handle breakage issues. One of the recalls was issued after it was discovered that a small metal coil could break from the device and remain in the patient’s knee if it’s not noticed by surgeons.

Some of the problem could be that the Attune Knee System entered the market through a process that allows medical devices to be sold sooner than devices that go through the traditional approval process. The FDA 510(k) pre-market approval process is a highly controversial program that requires device makers to submit a modicum of safety and study data and show that the device is substantially similar to a predicate device (a device that is already on the market).

Devices that go through the traditional approval process are required to conduct multiple rigorous clinical studies that prove the device is effective and safe. But for 510(k) approval, manufacturers may conduct small, short-term studies, even if the device, like an artificial knee, remains in the body for a decade or more.

Another problem with the program is that the FDA does not conduct a historical review of the predicate device to see if it has had post-market safety issues, if it’s been recalled, or even if it has caused patients to suffer injuries and adverse events. The process only requires the devices to be substantially similar.

What this means is that even though DePuy markets and promotes the Attune Knee System as having proprietary advances that make it better than competing devices, what the device maker actually showed the FDA was how similar the Attune Knee System is to other artificial knee implant devices on the market. However, the predicate devices that the Attune Knee System was compared to have their own problems. In fact, two of the predicate devices include the PFC Sigma Knee System and the Zimmer NexGen CR Knee System.  Both of these knee systems have reportedly caused patient complications, and the NexGen Knee is at the heart of mounting litigation.

We Can Help

Lawsuits are being filed on behalf of patients who received the Attune Knee System and suffered device malfunctions, injury, premature failures, and were forced to have revision surgery to replace the device and repair damage. If you were implanted with the Attune Knee System and experienced complications, failures, and had to have additional surgeries and have the device removed, contact us today to learn about how we can help and if you are entitled to damages.

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