Stryker Cobalt Toxicity—How Serious Is It?

As more and more metal hip implants are being recalled, those who were implanted with a Stryker hip device—believing it to be safe—are dismayed to find that Stryker cobalt toxicity is just one health risk associated with the Rejuvenate and ABGII. The Rejuvenate and ABGII Stryker implants are not “true” metal-on-metal implants due to the fact that they use a ceramic ball. Unfortunately, the Stryker implants share the same risks of fretting and corrosion. In fact, at the time of the recall, Stryker stated a higher-than-normal risk of implant failure from the fretting, corrosion and excess metal debris shedding into the body.

When Stryker introduced the ABGII and the Rejuvenate, there were no safety risks relayed to patients, particularly concerning Stryker cobalt toxicity.

One Woman’s Stryker Metal on Metal Poisoning Symptoms

One doctor detailed Stryker metal on metal poisoning symptoms among his patients; a representative case was a woman in her early seventies who suffered a variety of Stryker metal on metal poisoning symptoms following her Stryker hip implant three years prior. The woman suffered such Stryker metal on metal poisoning symptoms as neurological disorders (including cognitive decline) memory difficulties, depression, a continuous taste of metal in her mouth, severe headaches and mild levels of groin pain.

Although an x-ray showed a well-aligned implant, blood tests showed astronomical levels of cobalt and chromium—above 240 parts per million. The woman had experienced a cerebrovascular episode a year earlier, with Stryker metal on metal poisoning symptoms similar to a stroke: dizziness, disorientation, nausea and vertigo.

When Symptoms of Stryker Cobalt Toxicity Lead to Serious Health Issues in Patients

The Stryker Rejuvenate and ABGII were recalled in July, 2012, after a significant number of patients reported symptoms of Stryker cobalt toxicity and metallosis. The company stated a higher-than-normal risk of fretting and corrosion, leading to the excess generation of metal debris into the body. The symptoms of Stryker cobalt toxicity can cause a high failure rate of the recalled hip implants as well. Although Stryker has declined to comment on the actual failure rate of the ABGII and the Rejuvenate, some reports place that number as high as 40%.

The Stryker Hip Implant Recall and Its Effect on Implant Recipients

Stryker, a Michigan-based corporation, issued a Stryker hip implant recall in July, 2012. This Stryker hip implant recall came on the heels of an urgent field safety notification sent to hospitals and physicians in April, 2012. The notification as well as the Stryker hip implant recall stated a higher than normal risk of failure for the hip implants due to fretting and corrosion. Even though the Rejuvenate and ABGII hip implant devices use a ceramic ball, and are therefore not “true” metal-on-metal hip implants, they nonetheless are constructed of a cobalt and chromium neck, a titanium stem, and metal trunnions located on either end of the neck portion.

The metal neck juncture and the metal trunnions allow body fluids to become trapped, causing corrosion. The fretting and corrosion lead to tiny metal ions being sheared away from the device,

Possible Design Defects of the Stryker Rejuvenate

A recall of the Stryker Rejuvenate in July, 2012, caused those with the implant to wonder what steps they should take in order to protect their health and their future. An urgent field safety notification was sent out by Stryker regarding the Stryker Rejuvenate in April, 2012, stating that the device was more likely to fail due to excessive fretting and corrosion. The corrosion which could likely occur in many recipients of the Stryker Rejuvenate led to excess metal debris being released into the body. These metal ions could either pool in the hip tissue or travel to the bloodstream.

When the ions burrow into hip tissues, the patient can suffer inflammation of the hip, infection, chronic pain, degradation of hip tissue and serious loss of bone. When these symptoms reach serious levels, hip failure occurs and revision surgery becomes necessary. Metal toxicity can occur when the metal ions build up in the bloodstream among those with a Stryker Rejuvenate hip implant. Patients have varying responses to cobalt and chromium; some patients with relatively low levels of the metals become very sick while others with higher levels may not yet be exhibiting metal poisoning symptoms.

Large Study Shows Women 29% More Likely Than Men to Experience Hip Implant Failure

A recent study done in California which looked at more than 35,000 hip replacement surgeries across 46 hospitals in the Kaiser Permanente health system claims that hip replacements are more likely to fail in women than in men. This includes all types of hip implants—ceramic, polyethylene and metal-on-metal although. While fewer women are implanted with metal-on-metal hip implants, the failure rate of those types of implants was nearly twice as high for women as for men. The all-metal hip implants were marketed as being extremely durable, lasting fifteen years and more.