STRYKER KNEE


Ohio Product Liability Lawyer reviewing defective knee implant recalls & lawsuits for injured clients and plaintiffs nationwide
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Stryker Knee Implants Recalled 

investigating stryker knee recalls & implant injury cases

If an artificial Stryker knee replacement system fails for any reason, whether the device components prove defective or implant components wear down over time, revision surgery may be necessary.

Most revision procedures will include surgeons removing a faulty Stryker knee device and most likely replacing it with a new implant. Each year in the U.S., thousands of knee revision surgeries are performed after patients experience complications.

Experts from the American Academy of Orthopedic Surgeons warn that revision surgeries can cause significant damage, and even permanent injuries, as health risks are known to increase with each successive medical operation. Too often, patients are unaware of these risks when they undergo their initial replacement surgery.

Medical device companies, like Zimmer, Arthrex and Exactech, who market and distribute artificial joint products to consumers should clarify the risks, and take responsibility when their devices fail and cause serious injuries.

Joe Lyon is a highly-rated Cincinnati, Ohio knee implant recall lawyer and product liability attorney representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims.

Stryker Knee Implant Failure 

Stryker Knee revision surgery can be required after a patient develops an infection, experiences unusual pain, or finds a decreased range of motion after an implant malfunctions.

Recently, some recipients of defective knee implants have reported a loosening of device components, and an overall instability months or years after an initial implant operation.

The cause of knee implant loosening is not always clear, though high-impact activities, excessive body weight, and wear of implant components are all contributing factors. For anybody with an implant from Arthex, Exactech or another device maker, there is a long-term risk that revision surgery will be needed due to loosening or wear.

Another common reason for revision surgery is the occurrence of bone loss, which can occur from either a defective device design or from normal friction and excessive wear on the bones from implant components.

Implant recipients cannot expect artificial knees like the Arthrex or Exactech system to function perfectly forever, though there is a reasonable expectation from medical device companies that their products perform as they are marketed.

•    Loosening of an Implant—there have been multiple complaints from Zimmer, Arthrex and Exactech knee implant recipients of a general throbbing pain and instability that is due to a loosening of the device. This may be due to either faulty device design, and the bone may not fuse properly with an implant.
•    Bone Fracture—when a device is loosening, and creates unnatural friction and structural damage, it may result in bone fractures.
•    Infection—if a patient notices unusual swelling and inflammation in their knee after an implant surgery, or if blood tests indicate serious infection, a revision surgery may be needed to remove potentially dangerous components. Some devices have been known to cause metallosis, a type of serious metal poisoning from implanted components.

•    Knee Instability—a general instability or decreased range of motion may occur if knee and leg ligaments are damaged or improperly balanced during an initial replacement surgery.

Stryker Knee Implant Revision Surgery

Recovering from knee implant surgery can be long and painful. Rehabilitation is likely to last several months. It may come as a shock and great inconvenience when a device fails and another surgery is necessary.

A second surgery required to adjust or replace an implant raises the risk of complications. This can result in huge medical bills, serious emotional distress, and a great deal of time away from work. Lost wages and other damages can be recovered in timely lawsuits.

After receiving defective knee implants some patients may feel persistent pain or notice that their new joint is not as flexible as the joint was prior to the operation. This may be a symptom of a greater issue, and some complications that may follow include:

•    Blood clots
•    Knee joint immobility
•    Nerve damage
•    Muscle damage
•    Bone loss
•    Infection

Defective Stryker Knee Replacements

Recipients of defective Stryker knee replacements who experience any symptom of device failure such as serious throbbing pain, difficulty standing or moving, or feeling of instability should contact their implanting surgeon and a knee implant recall lawyer for immediate consultation.

Medical devices have been known to dissemble, cause bone fractures, damage nerves, cause infection, and other injuries. Stryker and other device companies issue recalls for their products, though sometimes thousands of patients are endangered before the faulty device is removed from the market.

This causes more revision surgeries, more potential injuries, and more lawsuits directed at the companies responsible for failing to properly test or warn American consumers.

Defective Knee Implant Injury

•    Fracturing
•    Loosening of components
•    Sizing issues
•    Risk of infection
•    Damage of muscle, bone or surrounding tissue
•    Mislabeled components
•    Metal debris
•    Assembly difficulties
•    Defective design
•    Contaminated materials

Stryker Knee Implant Recalls

There are around 600,000 total knee replacement surgeries performed in the U.S. each year, and those numbers are increasing year-on-year with an aging population. Medical devices can be tremendously helpful for those with decreased mobility, but can also worsen one’s quality of life if the device is in fact defective.

Medical device companies have said their products will improve a patient’s range of motion and act as a stable knee replacement. But many reports filed with the Food and Drug Administration (FDA) and with operating surgeons describe failures of some Stryker knee implants.

The Lyon Firm represents clients who have suffered through no fault of their own and deserve compensation for the pain and suffering brought on by a defective product.

Consumers have a right to file a lawsuits when a negligent company fails to properly test and warn consumers of the safety risks of a product. Knee implants can be the best medical decision a patient can make, but when the implant is ultimately defective, it can be one of the worst experiences of their life.

When Stryker knee implant defects cause injury and lead to revision surgery and extreme pain, The Lyon Firm can work on plaintiffs behalf to file a product liability lawsuit.

Knee Failure Studies

A study published in the Journal of Knee Surgery noted a high rate of early failure related to knee implant tibial components. The study scoured FDA reports and its adverse event database related to certain knee implants, as well as clinical and radiographic findings for patients who implanted with the faulty system.

The surgeons on record attributed knee implant failures to the debonding of the tibial implant-cement interface, a critical adhesive component used to hold an implant in place. If the tibial component of the knee implant loosens, the entire knee replacement may be destabilized.

Artificial knee implants are marketed as lasting a minimum of 15 years, but some are known to fail much sooner, often only a year or two after the implant was inserted.

photo of attorney Joe Lyon reviewing stryker knee implants
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Why are these cases important?

Many product liability cases have had a positive impact on public health and safety, and we have witnessed improved lives and future injuries prevented as companies are forced to remove products and change designs and warnings as a result of litigation.

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Questions about Product Liability & Case Types

What is a Product Liability Lawsuit?

Product liability lawsuits often contain causes of action for strict liability, negligence, and breach of warranty. Strict liability applies to different factors than negligence-based claims.

In negligence cases, the actions of the defendant are the focus. In strict liability claims, the focus is on the condition of a product at the time it left the manufacturer. If a product is determined to be defective, the company is liable for any foreseeable injuries that are in-part caused by the defective condition of the product.

What are some examples of Product Liability?
How is a Product Defined as Defective?
Ohio Definition of Defective

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.

(4) Misrepresentation:

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.

How do you prove design defects?

Risks:  The following factors are considered under Ohio law when determining the risks associated with the design of a product:  (1) the magnitude of the risk of injury; (2) ordinary consumer awareness of the risk for injury; (3) the likelihood of causing injury; (4) the violation of a private or public standard; and (5) the consumer’s expectation of the performance of the product and level of danger. Ohio Revised Code 2307.5 (B) Product Defective in Design or Formulation.

BenefitsThe following factors are considered under Ohio law when determining the benefits associated with product design: (1) the utility of the product; (2) availability of an alternative design; (3) the magnitude of risks associated with an alternative design. Ohio Revised Code 2307.5 (c)

Defenses for Defective Design(1) a pharmaceutical drug or medical device is not defective by design if it contains an adequate warning of an unavoidably unsafe aspect of the pharmaceutical or medical device; (2) the dangerous aspect is inherent to the product, recognizable, and cannot be eliminated without compromising the product’s usefulness; (3) a lack of a feasible alternative design. 2307.75 (d)(e)(f).

EXAMPLES:

What is a manufacturing defect?
  • A manufacturing defect is based on a defect that occurred during the manufacturing process. Many auto companies have been involved in this kind of product liability lawsuits in recent years, due to defective airbags, software defects, tire failure, and other dangerous manufacturing errors.

    Most manufacturing defect cases are based on a products deviation from the intended specification, formula, performance standards, or design model. In such cases, it may be easy to determine the product did not comply with the intended design.

    The product may be recalled as a specific lot is identified as being non-compliant and defective. A product may be defective in manufacture or construction, materials and assembly, and a manufacturer or distributor may be subject to strict liability, even though it exercised all possible care.  Ohio Revised Code 2307.74.


    Manufacturing Defect Examples:

What is a failure to warn lawsuit?

In determining whether a product is defective due to inadequate warning or instruction, evidence must be presented to prove:

  • The manufacturer knew, or in the exercise of reasonable care, should have known about a risk
  • A reasonable manufacturer would have provided a warning of the risk
  • The manufacturer failed to provide the warning
  • The person was injured due to a lack of warning. The same elements apply whether the claim is based on a warning present during the marketing or post-sale warnings.

Defenses to Failure to Warn Claims(1) the risk was open and obvious or a matter of common knowledge; and (2) in cases of a pharmaceutical drug or medical device, the warning was provided to the prescribing physician (“Learned Intermediary Doctrine”).

Many pharmaceutical companies have been targeted in failure to warn lawsuits for either failing to place warnings on medication guides and packaging or failing to properly test their product before putting it to market.


 

What are consumer product safety regulations?

Design and manufacturing defects result in thousands of product recalls each year in the United States, initiated by federal safety agencies. Following injury and illness, regardless of recall status, victims and plaintiffs may pursue legal action and contact a product liability lawyer to begin the litigation process. Rightful compensation can be sought and help plaintiffs recover medical costs and other related damages.

Product liability law overlaps with regulatory law, which are the systems of legislative rules and administrative agencies, and part of federal and state governments. These agencies regulate the safety of the products sold to the public. Examples include:

  • The Food and Drug Administration (FDA)
  • The National Highway Traffic Safety Administration (NHTSA;)
  • The Consumer Product Safety Commission (CPSC)

The listed government agencies, however, may initiate recalls of dangerous products but do not provide remedies or compensation for damages where an individual is injured due to the defective product.

Why should I hire The Lyon Firm?

Our Firm will help you find the answers.  The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered. 

 Experience:  Joe Lyon is an experienced Cincinnati Product Liability Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters.   Product Liability lawsuits can be complex and require industry experts to determine the root cause of an accident or injury.  Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results:  Mr. Lyon has obtained numerous seven and six figure results in personal injury,  automotive product liability, medical negligence, construction accidents, and auto dealership negligence casesThe cases have involved successfully litigating against some of  the largest companies in the world 

Your Right to Safety

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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


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