Stryker Defect Lawsuits include Implants Presenting Major Health Risk for Patients
For many years, Stryker hip implants have been plaguing thousands of patients in Ohio and across the country. As the incidences of adverse effect reports increases, more and more personal injury lawsuits emerge. Hip replacement systems are gaining in popularity, and can do wonders for a patient’s quality of life. However, too many patients have suffered the consequences of Stryker’s faulty medical devices.
Stryker has a history of personal injury claims against them. As a result, Stryker has recalled two metal hip products in the past—the Rejuvenate and ABG II were recalled over concerns that components could corrode, and cause pain and inflammation in the surrounding tissue. Like the recalled Rejuvenate and ABG II, Stryker’s Accolade V40 has been met with allegations of consumer injury.
Stryker’s metal-on-metal hip implants have caused similar problems to patients with Johnson & Johnson’s recalled DePuy ASR systems and other dangerous metal-on-metal hip replacements. The most common adverse health problems reported include premature implant failure and metal poisoning, which can lead to numerous secondary issues.
In 2014, Stryker reached a settlement that cost the company an estimated $1 billion, but the medical device company continued to manufacture other failing hip implant products.
Joe Lyon is a highly-rated Cincinnati recall lawyer and Ohio product liability attorney representing plaintiffs nationwide in a wide variety of medical device and Stryker defect claims.
In August, 2016, Stryker issued an Urgent Medical Device Product Field Action Notification for the Accolade and the LFIT V40, noting that they had received “higher-than-expected complaints” of failure. The hip systems are responsible for a number of complications, which cause severe pain, inflammation, loss of mobility, and more serious concerns such as metallosis.
Stryker has indicated in a letter that some models of the V40 femoral heads manufactured prior to 2011 have a higher than expected incidence of taper lock failure. Although there have been no recalls in the United States, the Accolade V40 has been recalled in both Canada and Australia.
There are potentially thousands of affected hip implants around the world as a result of the V40’s defective design. According to the FDA’s recent notice, over 42,000 potentially defective units have been distributed and implanted across the U.S. market and worldwide.
The Accolade V40, also known as the Stryker LFIT Anatomic CoCr V40, is an alloy femoral head that is used in conjunction with modular hip implants for hip replacement surgery. The Accolade V40 is believed to wear down prematurely due to the friction between the modular neck and stem. The resulting metallic debris can cause deterioration of tissue around the joint, and loosening of the hip replacement.
Stryker officials say potential taper lock failures may jeopardize the connection between the femoral head and femoral stem, causing issues that may include the following:
• Disassociation of femoral head from hip stem
• Excessive metallic debris
• Insufficient range of motion
Stryker’s Anatomic CoCr V40 Femoral Head is the third hip implant product that the company has recalled in the last five years. When a hip replacement fails, the device may lead to serious side effects. Patients implanted with defective LFIT Anatomic V40 Femoral Heads may suffer from:
• Loss of mobility
• Adverse local tissue reaction
• Joint instability
• Bone Fractures around the components
• Nerve Damage
• Need for revision surgery
Since its release in the U.S. market, there have been over 100 adverse events reported to the FDA associated with the LFIT model. Pain may develop gradually along with a decrease in range of motion, resulting in a need for revision surgery. Revision surgeries are often more complex than the initial surgeries and may result in longer recovery times and increased risks.
Metal-on-metal hip implants are the subject of many reports of serious complications. In one study in the British Medical Journal, researchers concluded that systemic metal ions may cause cardiovascular problems.
A recent study shows that some metal-on-metal implants are likely to fail much sooner than available alternatives. The research, published in 2012 in The Lancet, shows patients who received metal-on-metal implants had a substantially higher overall failure rate—twice the rate of ceramic hips, and three times the rate of metal-on-plastic implants.
Hip replacement patients should monitor for symptoms of metal poisoning. According to the FDA, the signs of metal toxicity include:
• Impaired kidney function
• Thyroid problems
• Cognitive impairment
• Skin rashes
• Hearing or vision impairments
• Cardiomyopathy—a condition that weakens the heart
After an initial settlement of around $1 billion was reached in 2014, Stryker expanded their hip replacement settlement to include patients who received the Stryker ABG II Modular Neck Hip Stem and the Rejuvenate Modular Neck Hip Stem models and had revision surgery between 2014 and December, 2016. The original settlement offered a $300,000 base award to injured patients.
Stryker now faces claims concerning the Accolade and LFIT V40 femoral head. Among concerns about the LFIT femoral head are a risk of spontaneous dislocation.
Product liability attorneys contend that the litigation has potential to include thousands of similar claims, pointing out that more than 100,000 LFIT V40 components may have been implanted in patients.
According to Stryker defect lawsuits filed in 2016, the company did not ask for the affected femoral heads to be returned and did not direct doctors to notify patients of the potential defect. The complaints claim that Stryker knew for years that the LFIT V40 femoral heads were defective and dangerous, but chose not to report the risks of using the components.
The most recent Stryker recall is similar to the Rejuvenate and ABGII recall that occurred in June 2012. Several hip implant lawsuits have been filed in U.S. courts on behalf of patients that have experienced Stryker femoral head failures. Lawyers allege that the components are defectively designed and manufactured.
Compensation may be available to individuals who allegedly suffered pain, disability, and other complications resulting from the taper lock failure of a Stryker Accolade or LFIT Anatomic CoCr V40 Femoral Head.
If you or a loved one has suffered an injury due to a defective hip replacement, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer critical questions regarding the Stryker recall.