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
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.
If you or a loved one suffered an injury due to a defective hip implant, and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.