Stryker Orthopedics has issued a recall in Canada and Australia for key component of thousands of hip replacement systems manufactured before 2011. The recall is a cause for concern in the United States for doctors and patients, and according to experts, Stryker will soon announce a hip implant recall in the U.S.
The recall is reportedly due to potential hazards of taper lock failures in the LFIT V40 femoral head. Stryker uses this component with Citation stem systems, which has already been recalled due to a large number of complaints that range from severe pain to serious health reactions to excessive metallic debris. Physicians have received recall letters, but patients have not received notice yet, as Stryker is still assessing the extent of the damage.
Joe Lyon is a highly-rated product liability lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims.
The Australian Therapeutic Goods Administration warned in a September, 2016 hazard alert that crucial components used in Stryker’s Citation hip replacements have higher-than-expected rates of failures. It has been identified that some LFIT V40 femoral heads manufactured before 2011 have high incidences of taper lock failures.
The Australian health agency identified seven Stryker models using the LFIT hip femoral heads, with head diameters ranging from 36 mm to 44 mm, which may cause issues for patients. Stryker’s products with similar specifications have been included in the hazard alert. Possible defective Stryker femoral heads are used in the following models:
• Accolade TMZF
• Accolade 2
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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.
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New recalls suggest Stryker LFIT femoral heads manufactured before 2011 are associated with dangerous 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 hip implant device wear and adverse reactions to metal debris. Patients may also experience the following dangerous side effects:
• Loss of mobility (trouble walking)
• Moderate to severe pain
• Adverse local tissue reactions (rashes)
• Implant dislocation
• Joint instability
• Bone fractures around the components
• Metallosis (reaction to metallic debris in blood)
Other symptoms of a failing hip implants include:
• Dead tissue around the implant
• Formation of cysts or pseudo-tumors
• Nerve damage
Stryker has reportedly sent a warning notice to orthopedic surgeons using their Citation hip implants. According to the warning, the Stryker LFIT hip implant components, used in the Citation units, may cause failures. Hip system failures where the femoral head connects to the femoral neck compromise the entire implant system and places a patient’s health in jeopardy.
Anybody with a Citation hip system should contact their doctor at the first sign of failure, and go for regular follow-up consultations to ensure the device is properly functioning. Unfortunately, many hip implant issues require invasive hip revision surgery.
Orthopedic surgeons and recipients of implants have reported hip failures in the Citation system similar to the Rejuvenate and ABGII recall that occurred in June 2012. All Stryker products with failing components are made of the same TMZF metal alloy including the Stryker Citation.
Numerous lawsuits were filed in U.S. courts in 2014 after many patients had suffered failures of Stryker LFIT V40 femoral heads. Lawyers alleged that the components were defectively designed and manufactured. Stryker has not disclosed the cause of the failures.
Patients with an affected implant should follow up with a health professional or implanting surgeon, particularly if they experience instability, pain, or loss of mobility.
American consumers are at the mercy of the lenient FDA approval process for new medical devices. Many defective products on the market, like hip implants, further injure patients looking for a better quality of life. Victims and attorneys are forcing medical device companies like Stryker to claim responsibility for the defective products they market and distribute.
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.