The Stryker Orthopaedics corporation is one of the largest orthopedic and medical device manufacturers in the world. The company has over 25,000 employees worldwide and an estimated annual revenue of $9 billion. Stryker is well known for its joint replacement products, most of which have been successful, but some of which including the the Rejuvenate and ABG II Modular-Neck hip stems have resulted in numerous medical injuries.
The Stryker Rejuvenate Modular Neck Stem hip device was approved in 2008 but subject to a warning letter and device recall in 2012 after numerous adverse events had been filed with the Food and Drug Administration (FDA). The device was designed to be more durable, longer lasting and safer for a patient in a younger demographic, who had a lifestyle that was still active.
The device’s design included two sections constructed of durable metals which were intended to increase stability and decrease the chance of erosion, however both the Rejuvenate and the ABG II did begin to corrode in many patients, resulting in multiple injuries even though the device was only on the market for less than four years.
In 2012, two safety warnings and a report were issued by the company and both devices were voluntarily recalled in the same year. Though worldwide manufacturing and sales had been discontinued, many patients had already been injured.
Rejuvenate Modular Neck Performance Claims
Stryker claimed that their Rejuvenate Modular Neck hip stem would provide patients with the following:
- Enhanced Stability – Stryker claimed that the Rejuvenate Modular Neck Stem more closely matched the biomechanics of the patient, reducing the risk of dislocation.
- Proven Modularity – With a variety of components, 8-10 different types of neck for both right and left sides and modular neck components allowed the physician to select the components based on the patient’s individual needs. Stryker stated, Every patient’s anatomy and lifestyle are different, which is why we have invested in developing cost-effective personalized hip solutions,”
- Intra-Operative Flexibility – Stryker claimed that the modular implant design accommodated most well-established surgical approaches provided instrumentation to be used in conjunction with the Rejuvenate system with enhanced ergonomics to streamline surgical workflow
The Stryker line of hip implants was also claimed to be much more corrosive resistant due to proprietary Stryker materials, all of which were said to be extremely hard and durable including Vitalium, an alloy of chromium and cobalt, along with a titanium coating. Both metals were chosen for their reported ability to resist corrosion and degradation.
Stryker Rejuvenate Side Effects
The Stryker Rejuvenate and ABG II hip implants have caused side effects in some patients such as:
- Metallosis – metal poisoning in surrounding tissue due to debris
- Necrosis and osteolysis – death and dissolution of bone and other tissue in the joint area due to metallosis
- Joint destabilization – erosion of the joint resulting in difficulty moving, muscle wasting and pain
- Revision surgery – removal and replacement of the failed device
- Reconstructive surgery – repair of damaged or fractured bone surrounding the implant
Many patients were subject to “adverse local tissue reaction” (ALTR) due to the effects of chromium and cobalt in the surrounding tissue. Some patients absorbed the toxic metals systemically, resulting in body-wide inflammation, neurological problems, fatigue and other symptoms.
Thousands of patients have been required to have revision or reconstructive surgery because of implant failure. Revision and reconstructive surgery are often much more invasive, causing more pain and requiring a much longer recovery period.
Faulty Stryker Hip Design
Most of the hip implants that have been approved by the FDA, were approved under a 510(k) Premarket Notification Process which allows the company to bypass expensive clinical testing before marketing the device. The Stryker Rejuvenate and ABG II hip products were both approved under the 510(k) process and were not implanted into humans before being sold to the public.
When a 510(k) process is used, doctors and patients are forced to wait for post-market surveillance or adverse event reports to identify any issues. By the time reports were compiled, the Rejuvenate device had already been placed in thousands of patients. The Stryker Rejuvenate device has been shown to be subject to metal corrosion which has resulted in numerous injuries due to metal toxicity and joint destabilization. Many of these patients have sued the company.
Stryker Hip Implant Lawsuits
Stryker Orthopaedics has been accused of designing a faulty product, failing to adequately test the product and for failure to warn the public about the potential risks of the Rejuvenate Modular Neck Stem hip system. Stryker faces more than 4000 lawsuits in federal, state, and local courts due to both, the ABG II and Rejuvenate Modular Neck Stem hip systems. Only a few of the lawsuits have been settled and many more lawsuits are expected. The company reported to regulatory officials that they expect to spend as much as $1.3 billion to settle claims. Learn more about Stryker hip replacement lawsuits here.