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DePuy Attune® Knee Replacement Approved through 510(k) Process

Regulating medical devices

The recent documentary, The Bleeding Edge, shone a light on the process for regulating the medical device industry, how what was supposed to be an exception to the rule has now basically become the standard process.

Failing Device Approved Through 510(k) Process

In 2010, the DePuy Attune Knee Replacement system was one of those devices approved by the FDA through the 510(k) provision. [Summary of Safety and Effectiveness pdf]

Since its approval, a growing number of patients with DePuy Attune knee replacement devices report loosening problems with the device. As such, lawsuits are being filed over the side effects when the devise fails.

On August 8, 2018, another complaint was filed in the U.S. District Court, Northern District of Texas by plaintiff Derrick Pearson (Case No. 3:18-cv-02073-B). Pearson underwent a total knee replacement in March of 2016 in which the DePuy Attune Knee Replacement System was implanted, including a fixed tibial insert and a fixed tibial baseplate.

After experiencing severe pain, discomfort, instability and difficulty walking, radiographs were taken which showed a loosening and debonding of the tibial tray. In May 2017, Pearson underwent revision surgery to remove and replace the device.

510(k): A Flawed Process?

The FDA’s implementation of the 510(k) process has received considerable criticism over the years.

In 2011, the Archives of Internal Medicine published a paper entitled, Medical Device Recalls and the FDA Approval Process. It reported, “Our findings reveal critical flaws in the current FDA device review system and its implementation.” It went on to report:

“Medical devices cleared through the less rigorous 510(k) pathway comprise more than two-thirds of the products that are recalled by the FDA because they could seriously harm patients or result in death. When devices that were intentionally exempt from any FDA review were added to the 510(k) devices, they comprise more than 3 out of 4 of the high-risk recalls.”

“An important question is whether the risks resulting from subsequently recalled devices could have been prevented if the 510(k) or exempt devices had been subject to a more rigorous review process.”

In May of 2018, the Institute of Medicine published a report, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.

In it, the report concludes that “the 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions. The 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.”

How well is our system working in regulating medical devices?

Is it time to Seek Legal Advice?

When a medical device, such as a knee replacement, prematurely fails, you can face many serious issues ranging from infections to muscle or nerve damage, bone loss and more. Revision surgeries are expensive and can result in many ongoing expenses. When you have questions about your specific situation, contact us for a free, no-obligation review of your case.

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