In July 2012, Stryker, a worldwide manufacturer of joint replacements and other medical devices, voluntarily recalled its ABG II hip replacement device amid reports of increased instances of early failure in patients who were implanted with the devices. Typically, a hip replacement implant is designed to last approximately 15-20 years, but the ABG II device was failing after only 2-to-3 years.
Why Were Stryker ABG II Devices Failing?
Unlike more common two-piece ball-and-socket hip replacements, Stryker ABG II hip implants were made up of four different components: a femoral stem; a metal neck; a ball, and an acetabular cup. More parts mean an increased likelihood of something going wrong. In this case, the parts carry the risk of fretting from too much movement, and given that they are made entirely from metal, they are more likely to shed microscopic particles, which can cause pain, swelling, inflammation and metal poisoning.
Another disconcerting fact about the Stryker ABG II is that its design was supposed to allow for a better fit for younger hip replacement patients. They have instead caused many of the same issues for recipients as more traditional implants.
Along with hip implants sold by other manufacturers, the ABG II hip replacement was pushed through an abbreviated U.S. Food and Drug Administration (FDA) testing method known as 510(k) which avoids premarket testing, and allows for fast-track approval if a medical device is “substantially similar” to a model that has already undergone clinical testing. Typically, this allows medical devices to be brought onto the market before testing can reveal potential side effects and other problems that could harm or injure recipients of devices like hip and other joint replacements.
Premarket testing can cost millions of dollars and take a long time to complete, so Stryker, and many other medical device manufacturers utilize the 510(k) loophole to get products to market more quickly. When a medical device is released onto market without premarket testing, the testing occurs during “post-market surveillance,” which means that the products are monitored for potential defects after being used in patients. Releasing the ABG II implant onto the market without testing may have contributed to the higher occurrence of side effects consistent with other metal-on-metal hip replacements that have injured thousands of people in the United States and worldwide.
Many Stryker ABG II hip replacement recipients have begun filing lawsuits against the company, to seek compensation for injuries and unforeseen medical expenses. The majority of Stryker plaintiffs have had to undergo revision surgery in order to remove and replace the recalled implant. A revision surgery is very often more difficult to perform and requires a lengthier recovery than the original procedure, due to tissue and bone damage that might occur as a result of the previous defective implant.
The Rottenstein Law Group Can Help if You’ve Been Injured by a Stryker Hip Replacement
It is important to consult your orthopedic surgeon to determine whether or not the symptoms you might be experiencing are consistent with a failed hip replacement implant, and if that implant was manufactured and sold by Stryker.
Lawsuits are currently being filed across the country, brought by recipients of the recalled Stryker implants. Plaintiffs are seeking compensation for pain, suffering, unforeseen medical expenses, lost wages, and other claims.
The lawyers at the Rottenstein Law Group have over 25 years of collective experience advocating for individuals who have been harmed by dangerous drugs and defective medical devices. If you feel you have reason to sue Stryker, fill out our confidential contact form or call 1-888-224-9712 for a free case evaluation. One of our lawyers will be in touch with you shortly.