Stryker Corporation recalled their Rejuvenate and ABG II hip replacement devices in June 2012 due to a risk of corrosion that could lead to pain, swelling and tissue damage. The devices, which were made of all metal, and known in the industry as “metal-on-metal,” have a higher failure rate, and may release metal into a patient’s bloodstream over time. This led the manufacturer to issue the Stryker hip recall in an effort to reduce the possibility of permanent damage from the devices.
Purpose of the Stryker Hip
Physicians often perform hip replacement surgery to relieve pain from arthritis or joint damage. The surgery requires replacement of the hip joint with a prosthetic implant. In 2008, the US Food and Drug Administration (FDA) approved the use of Rejuvenate, the metal-on-metal system. Reports began coming in to the FDA regarding problems with the devices, and, in 2012, the company issued a Stryker hip recall of the Rejuvenate and ABG systems. Because the recall came so soon after approval of the device, many believe that the company should have been aware of the problems before releasing the devices into the market.
Many Years of Complaints
As early as 2005, the FDA began receiving complaints regarding the hip replacement devices, and despite the complaints, the FDA did not require a Stryker hip recall. In 2012, the company voluntarily pulled the devices from the market. Some of the problems patients experienced were:
• Pain and discomfort, usually at the surgery site
• Corrosion in the implants, or devices that slipped out of joint
• Improper fit that caused bone fractures
• Squeaking, sometimes loud enough to be heard by others
• Heavy metal poisoning from metal fragments that entered the bloodstream.
Could Cost up to $390 Million
According to the company, the Stryker hip recall could cost the company as much as $390 million for patient testing and treatment, as well as new surgeries to replace the devices. Much of the cost will also be in the form of lawsuit payments as many suits have been filed against the company by patients who suffered after the devices were implanted. Patients are advised to see their doctor, even if they are not experiencing symptoms.
New Case Management Order Issued
According to Long Island Newsday, a new case management order was issued on August 13, 2013 in New Jersey Superior Court, designating the Stryker hip recall litigation for early mediation, and requiring that a formal mediation conference take place before December 15, 2013. The court documents indicate that more than 300 lawsuits have been filed as a result of the Stryker hip recall in New Jersey, as well as 198 lawsuits filed in Minnesota. According to a British Medical Journal article, published in February 2012, the devices are made from a cobalt-chromium alloy, and in some patients the metals release ions that seem to persist, especially if the devices begin to break down. Higher levels of these substances have been shown to put patients at a higher risk of cancer. In addition, cobalt toxicity could lead to nausea, vomiting, nerve damage, and even thyroid or cardiovascular disorders. Inhaled chromium leads to an increase in lung cancer, and can affect the reproductive system. In fact, the risk is so great, the FDA warned physicians not to implant metal-on-metal devices in women of child-bearing age.