Stryker is under more scrutiny as its hip replacement products are severely injuring patients throughout the country.Defective device attorneys warn anyone using Stryker’s Trident hip replacements of the recent litigation surrounding this product.
Stryker’s Trident Hip was developed to be an advancement in hip replacements, which are usually made of plastic components. Stryker’s product is instead are made with ceramic materials so they are supposed to be less likely to damage, break, or wear out. The FDA approved Trident for sale in 2003, and, in 2008, Stryker claimed it was selling Trident for 50% less than competitor’s products.
In the ensuing years, consumers began reporting an array of problematic side effects, including squeaking sounds, uneven erosion, and breaking down of the product internally. One report indicated that more than 7% of the products had squeaky hips. The FDA found numerous other defects associated with the product, including implant failure, pain, corrosion, fragments and fractures, and improper implant seating, which contributes to broached bones and bone fractures.
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Stryker has an illustrious list of product defect lawsuits and federal mishaps reaching back to 2005, when five major medical device manufacturers, including Stryker, were accused by the U.S. Department of Justice for giving illegal kickbacks to doctors. Two years later, Stryker agreed to pay the federal government over $16 million to resolve allegations of fraudulent health care billings. Again in 2007, FDA inspected the company’s plants in Cork, Ireland and Mahwah, New Jersey and charged the company with an array of citations and fines. Among the most serious citations included the presence of various chemicals and residuals in implant components, lack of final cleaning of finished implants, and failing to identify the source of a Staph contamination.
As a result of this FDA investigation, all devices manufactured in the Cork plant were permanently taken off the market and two Trident products were recalled. The deciding factor was Stryker’s failure to address and correct the mounting complaints of its costumers, which included severe injuries such as the device shattering inside the body. Stryker reportedly spent $50 million bringing its facilities up to federal standards. The FDA woes did not end there, however.
In 2012, Stryker recalled its Rejuvenate and ABG II modular components because of an influx of adverse health reports. Patients were experiencing metal toxicity from these products, requiring extensive revision surgery. Metal toxicity can cause severe injuries at the implant site including tissue death, bone loss, and potential damage to the spleen, liver, and kidneys. The same year Stryker began marketing a knee device that had not been yet cleared by the FDA, a major violation amounting to a $33 million settlement with the Department of Justice.
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Revision surgeries are extremely difficult and often traumatic for patients. Stryker markets over 57,000 products globally, and has the legal, ethical and moral responsibility to ensure its products are safe and effective. Stryker has repeatedly tried to undermine both consumers and the federal government, blatantly neglecting its responsibilities.
Victims of Stryker’s products may experience such symptoms of pain or swelling around the hip, bone fractures, squeaky joints, muscle loss, and fluid collection near the implants. These problems can lead to extensive and costly medical procedures. Stryker has advised its customers fitted with Rejuvenate, ABG II, or Trident implant systems who are experiencing persistent pain to undergo medical evaluations.
Lawsuits pertaining to Stryker products continue to mount, and have already resulted in millions of dollars worth of settlements. Victims are citing Stryker for numerous violations, including failure to warn, concealment of facts, and negligence. Product recall attorneys are willing to assist anyone suffering from Stryker device defects and will continue to offer the latest information regarding Stryker products.