Attune and FDA 510(k) Process

(No Longer Accepting Cases)

With a history of recalls and initial device approval obtained through the controversial 510(k) process, it is not surprising that some patients are choosing to speak to an Attune knee implant attorney to find out more about seeking compensation for the injuries they have sustained.

Attune has been recalled from the market four times in the last six years, including in 2012, 2014, 2015, and 2018. These recalls were issued for extraction hole thread burs, extraction handle issues, pin bushing overloading, packing problems, and the separation of a wire coil that can remain in the knee if unnoticed by the physician.

Part of the problem could be that DePuy applied for and received pre-market approval through the controversial 510(k) process, a program that allows devices to be sold on the market faster than with traditional approvals because it requires far less safety and efficacy data. Basically for approval through the 510(k) program, a device manufacturer must show their device is substantially similar to one that has already been approved for the market, called a predicate device.

But the FDA does not review the history of the predicate device prior to giving the new device approval, so it doesn’t know if the predicate device has a history of recalls, adverse events, or complaints. It only checks that the devices are substantially similar. This, plus the fact that the 510(k) process does not require the manufacturer to conduct, large, rigorous clinical trials to show the effectiveness or safety of the device, means that products can hit the market without proving they are safe.

So, while DePuy markets, promotes and advertises the Attune knee as with technologies that make it better than other knees, the manufacturer showed the device is substantially similar to others on the market. However, some of the predicate devices Attune was compared to have problems too, including the PFC Sigma Knee System or Darwin Knee and the Zimmer NexGen CR Knee System. In fact, Zimmer is facing mounting litigation over NexGen injury claims.

Patients who have to have additional surgeries to remove and replace Attune Knee implants may be eligible to seek justice and compensation for the injuries they sustained and the losses they suffered due to those injuries.

We Can Help

According to the law, device makers have a duty and responsibility to make sure their devices are effective and safe before they advertise and sell them. If a device maker fails their responsibility, it may be held accountable for injuries their product causes. Patients have the power to hold device makers liable for injuries, and we help make sure the playing field is even.

If you are an Attune Knee System patient who suffered infection and pain, device loosening or disbonding and had to have additional surgeries to have the implant removed or replaced, you may be entitled to seek justice and compensation. Contact us today to learn more about how we can help Attune Knee patients, and whether you are entitled to compensation for damages.