On July 6, 2012, the FDA announced that Stryker Orthopaedics had recalled its Rejuvenate and ABG II modular-neck hip replacement systems. In a press release, Stryker claimed that the recall was initiated due to potential risks with these hip replacement systems, including fretting and/or corrosion at the modular-neck junction of the system. Reports indicate that the Stryker systems had a high early failure rate, resulting in the need for patients to undergo revision surgeries to replace the devices more often than with other hip replacement systems. This announcement ended ongoing speculation concerning whether the Stryker hip replacement systems would be recalled.
In June of 2008, Stryker received approval from the Food and Drug Administration (FDA) to sell the Rejuvenate system in the United States. Stryker received further FDA approval to sell the ABG II in November of 2009. The Rejuvenate and ABG II were approved for sale through the FDA's controversial 510(K) medical device approval process. This process allows manufacturers to market and sell medical devices without any pre-market testing or clinical trials, provided the manufacturer can show that the device is "substantially similar" to a device already on the market. Rather than testing these artificial hips before they were marketed and sold, Stryker only conducted post-market surveillance. The trouble with medical devices approved under the 510(k) process is that their dangerous condition comes to light only after patients are harmed by the product. The 510(k) process has come under repeated criticism as the number of 510(k) approved medical device recalls grows.
Known complications associated with the Stryker Rejuvenate and ABG II systems include: blood toxicity from metal debris (Cobalt and Chromium); malalignment and loosening of components; increased pain; pseudotumors; metallosis; and tissue and bone necrosis. The treatment required to address these damages is often a complicated revision surgery. Revision surgery for a failed Rejuvenate or ABG II hip is a sophisticated procedure in which the entire femoral stem is removed and replaced with another, larger metal stem. Because the stem is inserted down the center of the femur bone, removal is quite traumatic, and frequently results in fractures to the femur itself, which then has to be repaired with more metal hardware. The end result is a complicated and prolonged recovery process, with a high potential for permanent loss of hip function.
The Stryker Rejuvenate and ABG II hip implants were marketed to and used in discrete parts of the United States. Boston, Massachusetts was one of the principal locations where surgeons implanted the Stryker hips until their recall. Because Boston-area hospitals were within the epicenter for Stryker implants, Massachusetts is becoming a hotbed of litigation surrounding the defects in the recalled Stryker hip systems.
SUGARMAN has formed a team of dedicated personal injury attorneys who represent patients with defective Stryker Rejuvenate and ABG II hips and other metal-on-metal hips. If you are experiencing difficulties with a Stryker Rejuvenate and ABG II hip implant or other hip prosthesis, please call SUGARMAN today to discuss your right to recover.