Did You Develop Metallosis or Other Serious Injury After Receiving a Stryker Hip Replacement?
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Hip replacement has been around for decades, ever since the first one was performed in 1960. Millions of these procedures have been performed since then, improving the mobility and lives of countless patients. Numerous improvements have been made since the original devices and procedures. However, not every device is safe for use in hip replacement surgery.
Over the years, certain devices have been linked to more than the normal amount of problems. One manufacturer which has been in the middle of the news with lawsuits is Stryker. Specifically, the Accolade, Meridian and Citation devices have been involved with these legal battles, especially when the LFIT-V40 femoral head is paired with them. The issue being claimed is that the devices are susceptible to corrosion which leads to many serious problems for the patients, including metal toxicity.
If you have received a Stryker hip replacement implant, contact us to learn more about the adverse events that have been associated with these devices. You may be eligible to seek compensation for injuries that resulted from a metal-on-metal hip replacement device.
What is Metallosis?
The devices used by Stryker are classified as metal-on-metal. That means the components are almost all metal instead of using plastic or some other material in part of the device. The Stryker Accolade, Meridian and Citation TMZF stem is made up of metal and paired with the LFIT-V40 femoral head which is made of chromium and cobalt. Mixing the metal may reduce the integrity of the device, allowing it to loosen inside the body, dislocate and break. Metal pieces often become shredded, allowing them to move throughout the body. This may result in serious injury which is often permanent. It can also lead to metallosis.
Metallosis is caused by these tiny metal shavings being leaked into the bloodstream and tissue. It can lead to osteolysis, which is commonly known as bone loss, and necrosis, which is known as tissue death. It can also cause metal poisoning which can result in death. In addition to these serious consequences, the device can also cause the ball of the thighbone to become dislocated from the socket in the hip bone.
Previous Stryker Issues
This is not the first time Stryker has been on the frontline of legal battles for their devices. In 2012, the devices which were recalled were the ABG II and Rejuvenate. The concerns were addressed with an Urgent Field Notice which stated that the devices can corrode along the neck and cause excessive metal debris along with more ion generation. The situation could lead to metallosis along with tissue death and bone loss. These devices also could cause dislocation, requiring revision surgery to correct the issues.
Yet the metals used in the more recent devices with Accolade, Meridian and Citation are the same metals which were used in the recalled devices from 2012. Stryker should have known about the complications from using these devices before putting them on the market. However, the manufacturer did not issue a recall for the devices, nor did it issue a warning to surgeons who use them in hip replacement procedures.
Even before this situation, Stryker had other issues with their products. In 2008, the Food and Drug Administration (FDA) issued a letter of warning about the Trident PSL and Hemispherical Acetabular Cups which were used in hip replacements. Even though the company maintained that these products were safe, they were recalled voluntarily because of failure to meet company standards during testing.
In fact, one study shows that between November 2002 and July 2013, Stryker has 231 out of 578 recalls, which was well above what any other manufacturer received. Of that number, 178 were Class II recalls.
The case in 2012 resulted in thousands of lawsuits being filed against Stryker for the defective components. The company reached a $2 billion settlement in 2014 for their ABG II and Rejuvenate models. Complaints are now being made against the manufacturer for its newer products. While Stryker has failed to recall its devices, it has changed the metal of the femoral head from titanium to titanium alloy, indicating the company is aware of the issue.
If you received one of the earlier Accolade, Meridian or Citation implants, you may be eligible for compensation if you have experienced complications as a result of the hip replacement surgery. Call us to find out more.
Research has shown that these devices increase the risk of complications. In 2015, a study was completed and published in Orthopedics which showed that over one-third of patients who had received the metal-on-metal hip replacement surgery had shown levels of cobalt and chromium which were significantly higher than with other devices. They also had more pain and almost 20 percent required revision surgery. Revision surgery requires the surgeon to remove the device and prepare the area for a replacement device. Sometimes however, the damage to surrounding tissue and bone is to severe for a replacement to be implanted.
An even earlier study which was published in the same publication in 2014 showed increased corrosion of the devices than what would be found with products that had alloys. Blood metal ion levels also tested higher in patients who had received these devices.
When the Stryker Devices Malfunction
As the two components move against each other, they can create friction which leads to tiny bits of metal being set loose into the system. They can get into the bloodstream and become lodged in the surrounding tissue.
People who have a malfunctioning device from Stryker may feel various symptoms, including:
- Pain in the hip or along the groin or down the leg
- Swelling along the hip joint
- Limping or a reduced ability to walk normally
- Sounds of popping, squeaking, clicking or grinding around the hip joint
As the metal moves around in the body, it can lead to serious complications. In addition, allowing these high levels of metal into the bloodstream can cause major reactions, which can lead to permanent damage. The problems are often long-term because it takes time for the metals to be released from the body and the process cannot be hurried. Some of the reactions you may experience from the metal-on-metal implants include the following:
- Skin reactions
- Changes in vision
- Changes in hearing
- Thyroid disfunction
- Kidney damage
- Weakened heart muscle
In addition, the person may also experience depression or notice cognitive impairment and other psychological issues which they may not attribute to the hip replacement. High levels of cobalt and chromium in the body can be toxic. Research has shown that it may lead to liver and kidney failure, neurological issues, renal tubular damage and cancer. Many of these conditions are life-threatening or permanent. Since it takes time for the metal on the devices to be released into the body, thousands of devices may be in use before the hazards are discovered.
The US is not the only country to recognize the dangers of these devices. Health Canada which is a regulatory agency for that country, issued a recall in September 2015 for the LFIT-V4 COCR femoral head due to the fact that surgeons were not able to connect it to the stem during the surgical procedure.
A second recall was issued in August 2016 due to failures of the taper lock in the components. The taper lock has the job of connecting the head to the neck. A failure of this component can lead to many serious consequences, including dislocation and inflammation. The devices impacted were those manufactured prior to 2011.
What Can You Do?
Numerous lawsuits have been filed against Stryker for the Accolade, Citation and Meridian devices, and more patients are expected to file in the near future. If you or a loved one has received one of these implants and have experienced the above-mentioned symptoms of metallosis or even gone through revision surgery, you may be entitled to compensation for your issues.
You may receive compensation for the following:
- Previous medical costs
- Future medical costs
- Lost wages
- Future earning ability
- Pain and suffering
- Emotional distress
For decades we have fought for the rights of patients harmed by the medical devices they depend on. We know that device manufacturers have a high duty to ensure their products are safe before they hit the market. When someone is harmed by a device, we hold the manufacturers responsible and help victims get the compensation they need and deserve. If you have suffered metallosis or another serious adverse event from your hip replacement device, contact us today to learn more about how we can help. We will fight on your behalf to maximize your compensation for the injuries you have suffered. Contact us for a free consultation and learn more about your rights, including your right to seek justice and compensation for your injuries and losses. If you are eligible for compensation, we will initiate a lawsuit on your behalf to help you recover damages.