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Was 510(k) Approval Process to Blame for Stryker Hip Implant Recall?

Written by Ankin Law Office

Last month Styker Othropedics announced that it was recalling its Rejuvenate and ABG II Modular-Neck Hip Implant Systems and discontinuing global production of the implant systems. As we reported, the Stryker hip implants were recalled due to risks of corrosion and fretting which can damage or injure surrounding tissues that may result in severe pain, inflammation, metal poisoning, tissue death, bone damage, pseudotumers, gait issues, and other serious problems. Patients may require a subsequent corrective surgery to remove and replace the recalled Stryker hip product.

Some critics question whether the problems associated with the recalled Stryker hip implant were the result of inadequate medical testing. Like other metal-on-metal hip implants, including the DePuy ASR, which was recalled in 2010, the Stryker ABG II received fast-track FDA approval through the 510(k) approval process, which allows manufacturers to avoid conducting long-term safety studies of new devices as long as they are “substantially similar” to existing devices. Because Stryker claimed that the Stryker Rejuvenate Modular Hip was “similar” to other existing hip implants, long-term safety studies of the metal hip were not conducted.

In order to qualify for the 510(k) abbreviated approval process, a manufacturer that wants to introduce a new medical device or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected must provide the FDA with a Premarket Notification (PMA) in the form of a 510(k) submission at least 90 days in advance of commercial distribution so that the FDA can determine if the device is “substantially equivalent” to a device already placed in one of the FDA’s three classification categories.  After the 510(k) has been submitted, the manufacturer must receive premarket clearance from the FDA before the device can be commercially distributed.

The 510(k) approval process was designed to ensure that devices that are substantially equivalent to devices already legally in commercial distribution are at least as safe and effective as the preexisting medical device, but some question whether additional medical testing would have prevent recalls such as the Stryker hip implant recall.

What to Do If You Have Received One of the Recalled Hip Implants

Patients who have received the recalled Styker hip implants should consult with their doctor immediately. If you are uncertain about whether you have one of the recalled products implant, you should also contact your doctor or consult your medical records. A patient call center has been established and patients can call (888) 317-0200 or visit for additional information.

If you suspect that your hip implant system is causing medical problems, such as swelling or pain, you should see your doctor immediately. You may also wish to consult with a skilled hip implant attorney as you may be entitled to compensation for injuries, including medical expenses, lost wages, and pain and suffering, in a product liability or medical malpractice lawsuit. Contact the Chicago product liability lawyers at Ankin Law Offices, LLC at (312) 600-0000 to learn more about the Stryker hip implant recall.

Categories: Product Liability