Texas Stryker Hip Lawyer – Texas Stryker Hip Recall Lawsuit – Texas Stryker Hip Implant Settlements
If you or a loved one suffered certain side effects after having a particular stryker hip implant you may be entitled to financial compensation from the manufacturer. Call us today to get the facts. Toll Free 1-866-777-2557 or use our online contact form and a Texas Stryker Hip Lawyer will get back to you within 24 hours to answer your questions and discuss your possible claim. This is a free, no obligation case review and there are no legal fees unless you receive money at the end of the case. Time is limited, so please call today.
Stryker Hip Replacement Lawsuit
Stryker Rejuvenate Hip Recalls and Complications
In 2008 and 2009, The Stryker Corporation, one of the largest orthopedic device manufacturers in the world, got FDA approval for its Rejuvenate and ABG II hip implant systems. This Michigan-based company has operations in over 100 countries around the world and has annual sales of nearly $9 billion.
Stryker Rejuvenate and ABG II hip replacement systems were on the market for only about three years after they were approved by the FDA. The company issued a voluntary recall in 2012. In the recall press release, it cited problems with fretting and corrosion at the modular-neck junction. By that time, the FDA had already had more than 60 reported adverse events associated with the hip replacement system that dealt with metal toxicity.
Stryker Rejuvenate and Metal Toxicity
Stryker made the determination to issue a voluntary recall after reviewing post-market studies that indicated that as the modular neck and stems of the system wore down, they would release metal debris into the body that can damage the surrounding bone and issues, and ultimately lead to more harmful results as well. What they found was a form of metal poisoning that resulted from the cobalt chromium and titanium alloy materials. The condition is often referred to as metallosis, and it commonly occurs in metal-on-metal medical device implants.
Although Stryker’s Rejuvenate and ABG II systems are made of metal, they are not technically considered metal-on-metal systems because there is no metal ball rubbing against a metal socket. Instead, the systems have modular necks, which still ultimately results in a metal-on-metal junction that can release metal debris into the blood stream and surrounding tissue.
The FDA’s Lack of Oversight
The FDA’s approval system for products like Stryker’s Rejuvenate and ABG II may have contributed to the problems associated with the hip replacements systems. Both systems were approved by the FDA, but they went through the FDA’s 510(k) Premarket Notification Process. When a product is in this program, it can be approved and offered to the public without undergoing the traditional clinical trials beforehand.
A product qualifies for this program by a showing that it is “substantially similar” to other products that have already received full FDA approval. For Stryker, that meant that its systems could have FDA approval because there were already several similar products on the market at the time of its approval application.
Using this process meant that Stryker only had to do after-market studies to ensure the product’s safety. One of the biggest problems with the Stryker’s hip implant devices and this application process was that the Stryker devices were substantially similar to other metal-on-metal hip replacement systems that were already having complications after being implanted into a patient.