Minnesota plaintiff Paul Donnay is suing Stryker Corporation for the injuries he sustained from the Stryker Rejuvenate Modular Primary Hip System. Donnay alleges that he suffered from metallosis, device failure, and other severe injuries as a direct result of the device.

On Aug. 4, 2011, Donnay underwent complete left hip replacement, choosing the Stryker Rejuvenate module as his hip module of choice.  However, several months after the implant, the plaintiff started feeling pain and immobility from the surgical area.  Medical examination found that the entire surgical area had been infected, and that his blood had a dangerous level of metal that descended directly from the device’s metal corrosion.

As a result of the defective design on the metal-on-metal hip module, Donnay was forced to undergo an additional surgery to have the device removed on March 28, 2013. The plaintiff had a replacement hip module installed to maintain his physical mobility.  The revision surgery is considered longer, more invasive, much more taxing, and significantly more expensive.  Donnay is still recovering from the revision surgery, and will most likely be slightly impaired for the rest of his life.  Donnay states that if he had known that if the device had such a possible device failure possibility, he never would have used it.

Instead, Donnay and his physicians were led to believe that the device was safe for human use, and implanted the device without much further consideration.  There were no warnings or indications to indicate the side effects the plaintiff suffered, nor were there any special instruction for surgeons.  Stryker made no effort to notify the plaintiff of the possible side effects that came with the device.

So, for being directly responsible for manufacturing, distributing, marketing, and selling a dangerous product, Donnay is suing Stryker Corporation.  The charges include: negligence, false advertising, concealing information, and misrepresenting a product.

Overview of Metal-on-Metal Hip Replacement Complications

On June 3, 2008, Stryker received U.S. Food and Drug Administration (FDA) approval to sell the Rejuvenate System in the United States, as a metal-on-metal hip module for patient.  Like other hip replacement systems, this device was meant to be used for patients with failing pelvic joints, or severely damaged hip bones.  Also similar to other metal-on-metal hip module, the Rejuvenate System was thought to be overtly superior to its plastic or ceramic counterparts, because metal is more durable and longer-lasting.  Additionally, younger patients in need of a hip replacement often opt for metal-on-metal options because the device is said to take great physical activity than the other options.

According to the defendant company, the device is composed of some of Stryker’s most commonly used design metals, including a plasma spray coating of commercially pure titanium and hydroxyapatite, which is used for the stem of the device.  The neck is also sprayed with a liquid metal, but is composed of cobalt and chromium.  Stryker boasted that the Rejuvenate System was specifically designed for strength and durability, and that the metals used on the device were resistant to fretting and corrosion.  This statement was obviously disproved as the injury reports submitted those side effects, along with several other complications which resulted from those occurrences.

Medical experts state that all metal-on-metal hip modules are prone to fretting and corrosion due to the natural interaction of the ball and socket joints of the devices.  Metal ions are shed from the device, and into the patient’s bloodstream, causing infection, metallosis, tissue damage, device failure, and other debilitating complications.

These complications were so severe, that the Rejuvenate was eventually recalled by the FDA in 2012, with many other metal-on-metal hip modules following.  This action came too late to many patients, as many of them are submitting lawsuits against the manufacturing companies.

Stryker Litigation Movement

This case is Paul Donnay vs. Stryker Corporation, Case No. 0:13-cv-02459-DWF-FLN, in the United States District Court of Minnesota.