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 product liability lawyer representing plaintiffs nationwide in a wide variety of civil litigation 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
• Accolade 2
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.
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.