Stryker Orthopedics has recalled a key component of thousands of hip replacement systems in Australia and Canada including the Stryker Meridian implant. The Stryker recalls are cause for concern in the United States for doctors and patients, where hip implants are increasingly common.
Medical experts say Stryker will soon announce a hip implant recall in the U.S. due to higher than expected complaints of taper lock failures. The Stryker LFIT V40 femoral head, used in Meridian hip replacement devices, has already been recalled in other countries due to a large number of complaints that range from minor inflammation to dangerous health reactions to excessive metallic debris.
The potential hazards implicate the LFIT head, which attaches to Meridian stem systems. Physicians and surgeons have received recall letters, but patients have not yet received notice, as Stryker is still assessing the extent of the damage.
Joe Lyon is a highly-rated Cincinnati recall lawyer and Ohio product liability attorney representing plaintiffs nationwide in a wide variety of civil litigation and medical device claims.
In September, 2016, the Australian Therapeutic Goods Administration warned in a hazard alert that the modular components used in Stryker’s Meridian hip replacements have “higher-than-expected” rates of failures. The health agency suggests that some LFIT Anatomic CoCr V40 femoral heads manufactured before 2011 have high incidences of taper lock failures.
Australian officials have identified seven models using the Stryker LFIT hip femoral heads, with head diameters ranging from 36 mm to 44 mm, which may cause issues for patients. An entire line of Stryker’s products with similar specifications has been included in the hazard alert. The affected Stryker femoral heads are used in the following models:
• Accolade TMZF
• Rejuvenate ABG
• Stryker Hip
The newly released information suggests Stryker LFIT femoral heads manufactured before 2011 are associated with catastrophic failure and metallosis.
The U.S. Food and Drug Administration (FDA) has warned in the past that certain patients, including female patients, are at risk for increased device wear and adverse reactions to metal debris. With defective implants, patients may experience the following side effects:
• Loss of mobility
• Severe pain
• Bone fractures
• Implant dislocation
• Adverse tissue reactions (allergic reactions to metallic debris)
• Joint instability
• Formation of cysts or pseudo-tumors
• Cobalt or chromium poisoning
• Nerve damage
Stryker officials recently sent a warning notice to orthopedic surgeons using their hip implants. According to the warning, Stryker acknowledges the LFIT hip implant components, used in the Meridian units, may cause failures. Hip system failures where the femoral head connects to the femoral neck compromise the entire system and the patient’s health.
Anybody with a Meridian hip system should contact their doctor if there are symptoms of failure. Many hip implant issues require extensive and painful hip revision surgery.
The reported hip implant failures in the Meridian system are similar to the Rejuvenate and ABGII recall that occurred in June 2012. All three Stryker products with failing components are made of the same TMZF metal alloy.
In 2014, several lawsuits were filed in U.S. courts on behalf of patients that had experienced Stryker femoral head failures. Lawyers alleged that the components were defectively designed and manufactured. To date, Stryker has not disclosed the cause of the failures.
Patients with a potential defective hip system should follow up with a health professional or implanting surgeon, particularly if they experience pain, loss of mobility, or instability.
The FDA approval process for new medical devices is remarkably lenient, and as a result many defective products like hip implants injure American consumers. Victims and attorneys are working to force medical device companies like Stryker to claim responsibility for the defective and unsafe products they market and distribute.
ABOUT THE LYON FIRM
Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.
The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.
NO COST UNLESS WE WIN
The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.
Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.
When a medical device has the potential to fail and cause injury, companies should voluntarily issue a recall. When a company injures patients with defective medical devices, a medical device lawyer may help you recover financial losses, medical expenses and other damages incurred through litigation.
A product is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of product defects. The following are Cincinnati product liability and strict liability claims available in Ohio and in most jurisdictions nationwide:
(1) Manufacturing/ Construction Defect:
These issues arise where the product is released from the factory in a manner that deviates from the intended design or specifications. The defect can be a result of using the wrong materials, including the wrong or completely foreign materials (e.g., Tylenol contamination, food poisoning, damaged car part from factory installation).
As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.
(2) Defective design and/or formulation:
Defective design product liability cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer.
Federal regulations set minimum standards for the design of many consumer products, and preemption defenses may preclude liability in some situations if the manufacturer follows and obtains federal approval for a product. Automotive recalls and product liability cases are usually a result of a defective design. Common cases include the Toyota Brake Recall, Chrysler Gen III seat belt buckle, lap belt only cases, Metal on Metal hip implants, transvaginal mesh.)
(3) Failure to warn or inadequate warning or instruction associated with the product:
All consumer products come with necessary and appropriate warnings and instructions for use. If the lack of a warning makes the product and use of the product unsafe, the manufacturer is liable for the failure to place the warning. The most common area of litigation for failure to warn is in pharmaceutical litigation.
Pharmaceutical manufacturers are required to warn of the known or foreseeable side effects and update the warnings in a timely manner. Litigation arises where there is evidence the manufacturer failed to timely update a warning in light of new data or simply ignored the risk and failed to conduct sufficient research to identify and then disclose the risk.
The product fails to conform to a representation or warranty. Warranty claims are more common in commercial and economic loss cases than in personal injury cases. In many States, The Product Liability Act does not apply to cases with only economic loss, because the Commercial Code provides recourse for breach of warranty.
The warranty may be written or implied based upon the products intended purpose and merchantability. An example of a breach of warranty cases are cases involving automotive defects.
The normal lifespan for a hip replacement is about 15 to 20 years, but defective products may fail much earlier than expected.
There are several models on the market, some made of plastic, and some metal on metal hips that have been known to cause problems.
Yes, any foreign material implanted into the human body may not be tolerated, but this is rare.
Pain, inflammation, infection, immobility and a sense of instability are all good signs there may be a problem with your hip implant.
Defective products on the market present safety and health hazards for adults and children. Cheap and defective products may pose fire and burn risks; electrocution, strangulation and choking risks; and severe health risks. The manufacturers of consumer products have a duty to foresee potential injury and properly design and test products before they are released.
Companies must also properly warn consumers of any risks associated with their products. Any failure to protect consumers that results in accidents and injury can lead to lawsuits filed by plaintiffs and their Cincinnati product liability lawyer
The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a defective product or recalled product to obtain just compensation under the law.
Nationwide Consolidation in U.S. District Court, Northern District of Ohio. The Depuy ASR Hip design was plagued with problems related to premature loosening and metallosis, caused by chromium and cobalt entering the blood stream. The resulting injuries were a result of the metal-on-metal friction inherent with the design of the product. Depuy recalled the ASR and entered into a global settlement valued at $2.5 Billion to cover an estimated 8,000 patients. The Lyon Firm represented several clients in the original settlement and continues to be active in this litigation. The settlement funds provided compensation for the revision surgeries, including compensating for medical costs, lost wages, and pain and suffering.
Nationwide Consolidation in U.S District Court, Northern District of Indiana. Similar to the Depuy ASR, the Biomet metal-on-metal hip design allegedly contributed to premature hip failures and metallosis due to the metal friction. Biomet entered into a global settlement valued at $56 million to cover a few thousand claims. The Lyon Firm represented several plaintiffs in the original settlement and continues to be active in this litigation.