Stryker Rejuvenate and ABG II Hip Replacement Products
Stryker Rejuvenate and ABG II modular hip implants were introduced to the market in 2009 after Stryker received FDA approval through what is known as the 510(k) approval process. It has been estimated that 20,000 patients received Rejuvenate or ABG II hip implants between 2009 and 2012.
The Rejuvenate and ABG II hip implant systems are different from other hip implant systems in that they have separate stem and neck components, both of which are made up of metals. When the metal neck piece rubs against the metal stem, this causes fretting, galvanization, and corrosion, which releases metal debris into the bloodstream and surrounding tissue. Patients who were surgically implanted with the Rejuvenate or ABG II hip implants have experienced a number of problems from the corrosion and fretting. Soft tissue damage and destruction around the implant site are common. Increased levels of chromium and cobalt are being found in the blood of patients. When toxic levels of metal debris, such as cobalt and chromium, are released into the bloodstream, a condition known as metallosis occurs. Metallosis is an adverse reaction by the body to heavy metals in the body. This condition can result in pain, inflammation, decreased mobility, failure around the hip joint, and the development of pseudotumors. Often, it is recommended that the patient undergo revision surgery, which involves removing the recalled Stryker hip components and replacing them with a different product.
In April of 2012, Stryker issued an Urgent Field Safety Notice to surgeons and hospitals throughout the U.S., acknowledging that Stryker had received reports of failures of these hip implants. The Notice specifically referred to failures of the junction between the metal neck and metal stem due to corrosion and fretting and other complications, including tissue necrosis, adverse tissue reaction, metallosis, and pseudotomor formation. Interestingly, almost immediately after the Urgent Field Safety Notice, Stryker recalled the Rejuvenate and ABG II systems in Canada, but did not recall the products in the U.S. at that time. It was not until the first week of July of 2012 that Stryker issued a voluntary recall of all Rejuvenate and ABG II hip replacement systems in the U.S. As part of the July 2012 recall notice, Stryker once again cited reports of device failure due to heavy metal fretting and corrosion.
Patients who were surgically implanted with the Stryker Rejuvenate or ABG II products and who feel their hip is not functioning properly should contact their orthopedic surgeon for further evaluation. Patients can also get a simple blood test to determine whether there are increased levels of cobalt and chromium in their bloodstream, sometimes referred to as metallosis.
Cases have been filed around the country on behalf of patients injured by the defective Stryker hip implants. Long before the Stryker hip replacement recall, the attorneys at Suthers Law Firm were investigating claims related to defective metal-on-metal hip replacement products, and representing victims injured by metal-on-metal hips that were manufactured by other companies. Consequently, we understand the regulatory history behind these products and the injuries and damage these products have caused to patients. Patients who have experienced such injuries may be entitled to compensation, including the cost associated with revision surgery to remove the recalled Stryker products.
The Suthers Law Firm is presently representing numerous individuals in pending claims against Stryker, involving the recalled Rejuvenate and ABG II hip replacement components. If you or a loved one believe you have suffered injuries as a result of one of these hip implant devices, or your physician has recommend revision surgery to remove the defective product, contact the experienced defective medical device attorneys at Suthers Law Firm on our toll free number, 1-800-320-2384, for a free consultation.