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.
Unlike DePuy Orthopaedics’ ASR hip systems that were recalled in August, 2010, the Stryker Rejuvenate is not a true metal-on-metal hip device. It does, however, have metal-on-metal components. In addition to the high early failure rate, these metal-on-metal components are believed to be responsible for the development of metallosis in a percentage of patients. Metallosis is a painful condition that a patient can develop when metal-on-metal components rub against each other, causing friction and the release of metal ions into surrounding bone and tissue. The Stryker hip systems are, however, similar to DePuy Orthopaedics’ ASR hip systems in that both systems were approved 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. The 510(k) process has come under repeated criticism as the number of 510(k) approved medical device recalls grows.
If you had Stryker Rejuvenate Modular and ABG II components implanted or are unsure whether or not your hip replacement system is subject to the recall, you should contact your surgeon as soon as possible. Stryker has also released a list of frequently asked questions for patients.
In addition to receiving the appropriate medical care, patients who have had these defective hips implanted may have legal recourse. SUGARMAN has formed a team led by partners Stephen Sugarman and Benjamin Zimmermann to represent clients who have been injured as a result of defective Stryker Rejuvenate Modular and ABG II hip implants. Please continue to follow our INSIGHTS blog for further details and developments regarding the Stryker hip recall. If you have any questions regarding a Stryker hip implant, please call Stephen or Ben at 617-542-1000 or email, firstname.lastname@example.org or email@example.com.