Source: Understanding the Stryker hip replacement recall.

Understanding the Stryker hip replacement recall

BY JENNA CYPRUS     AUG 7, 2014 IN HEALTH

People who have received hip or other joint implants within the past five years have been startled by the massive Stryker hip replacement recall. The recall affected about 1 million patients around the world.

Behind the recall is a condition — cobalt toxicity — about which little is known regarding the long-term effects. Researchers and personal injury lawyers alike have been laboring to clarify the condition, as well as identify what level of responsibility the medical device manufacturer must shoulder for the negative effects some patients have experienced.

How the Stryker recall occurred

In 2009 and 2010, medical device manufacturer Stryker promoted two new hip implant devices: The Rejuvenate and the ABG II. At the time, the firm touted these products as the “latest evolution” among its hip replacement devices.

The construction of the hip implants included neck pieces composed of cobalt and chromium, as well as titanium alloy stems. The structure led to the various kinds of metal rubbing together during patients’ customary movements.

The problems with Stryker’s hip implants surfaced in June 2012, when the company issued a recall for its ABG II and Rejuvenate devices. Patients experienced heightened heavy meal levels in their blood after corrosion and/or fretting caused metal debris to issue from these devices.

Studies of the faulty hip devices indicated that malfunctions within the implants contributed to unnecessary friction, which ultimately led to metal particles entering recipients’ blood streams. The manufacturers might have constructed the devices too loosely or placed cups at too steep an angle for the joint to flex normally.

As the cobalt concentrations in their blood increased, several patients began to experience metallosis, a condition characterized by fluid buildup (edema), and damaged or swollen hip tissue. These symptoms frequently required surgery to remove the faulty Stryker hip and replace it with an alternative device.

Cobalt toxicity, and its lasting effects

Although researchers have conducted a modest amount of research regarding metallosis caused by excess cobalt in the blood, the enduring impact of this condition remains unclear.

At trace levels, cobalt represents a normal — and even beneficial — element in humans. However, when excess amounts of cobalt enter the body through the skin, lungs, or digestive system, cobalt poisoning results.

In the case of the Stryker hip implants, the grinding of the ball joint inside its metal cup produced tiny particles, or ions, small enough to enter the bloodstream. Once cobalt levels reach a concentration above 4 micrograms per liter in the blood, individuals may begin to experience effects such as cognitive symptoms, neurotoxic symptoms, vision problems, and hearing loss. Such symptoms may cause significant impairment to patients.

Although no epidemiological studies have uncovered a clear correlation between cobalt toxicity and cancer or other chronic illnesses, the unprecedented nature of the case means only time can give researchers a clear understanding of the lasting impacts.

Regardless of whether excess metals from the hip implants result in long-term negative health outcomes, however, the patients impacted by metallosis tied to the faulty devices clearly faced strains on their health from having to undergo additional surgeries to replace the implants.

Current court cases that address the Stryker recall

Since the company issued the recall in 2012, patients in various states (including Texas, Pennsylvania, Oregon, Ohio, New York, Illinois, Colorado, California, and Alabama) have filed personal injury claims against the manufacturer of the device.

The plaintiffs blame Stryker for failing to perform clinical testing prior to placing the hip implants on the market, despite commonly available data in the medical community regarding the risks of corrosion and metallosis among recipients of artificial joints composed of titanium, chromium, and cobalt.

As Stryker organizes its defense in these many court actions, the firm will have a significant challenge to prove a lack of negligence in creating the devices and releasing them into the market.

Seeking legal recourse for medical product-related maladies

The purpose of medical implant devices is to improve individuals’ health and mobility, not to diminish it. When individuals suffer from pain, illness, or diminished freedom of movement as a result of a company’s neglect or malpractice, they deserve compensation for their lost quality of life.

If you or a loved one have experienced negative health effects from a medical implant built by Stryker or another medical device manufacturer, a qualified personal injury attorney can help you navigate your legal options. Together, those affected by such product defects can hold companies accountable for their actions.