Metal-on-metal Hip Device Implanted Experience Serious Complications. Hip replacement surgery can ease the pain from a damaged joint and help the recipient regain lost mobility, but many people who have a metal-on-metal hip device implanted experience serious complications and have to have undergo another surgery to replace the defective device.
Stryker Corp., a major manufacturer of metal-on-metal hip replacement devices, face thousands of lawsuits over high failure rates associated with the hips they make.
Doctors and patients allege that the Stryker LFIT metal hip implant is defective and prone to high rates of complications and failure.
According to the Centers for Disease Control and Prevention (CDC), more than 300,000 Americans undergo total hip replacement surgery every year. Personal injury law firm Parker Waichman notes that the risk of complications is greater when a defective metal-on-metal hip implant device is used.
Serious Concerns About Stryker LFIT Metal Hip Implant
Stryker recently issued a safety alert to surgeons to warn that the Striker LFIT metal hip implant components could cause serious injuries. In August 2016, Stryker sent an urgent recall notification to orthopedic surgeons across the country explaining the dangers associated with particular sizes of the Stryker LFIT metal hip implant manufactured before 2011.
Government regulatory agencies in Canada and Australia have also issued major safety announcements to doctors and patients about the high rate of failure for the Stryker LFIT metal hip implant, Top Class Actions reports.
Health Canada issued a recall of these components, citing “higher than expected complaints of…failure.” In September 2016, the Australian Government Department of Health issued a hazard alert for the Stryker LFIT metal hip implant, calling attention to components manufactured before 2011.
Complications Associated with the Stryker LFIT Metal Hip Implant
Metal-on-metal hip devices like the Stryker LFIT metal hip implant were marketed with the promised of greater durability and improved recovery times compared to older hip implant devices made from materials like ceramic or plastic.
Durability is an important consideration in choosing a hip replacement device, especially for the people who are having a hip replacement in their forties or fifties.
Younger hip recipients want the most durable hip so they will not have to undergo as many repeat surgeries. Older hip designs typically last about 15 years, meaning that people who have a hip replacement in their forties or fifties might need to undergo the procedure two or even three more times in their life.
Device manufacturers believed all-metal devices would last longer than previous devices did. Unfortunately, metal-on-metal hip implants have not met these expectations. During normal movement, as the hip’s metal components rub against each other, metallic debris is released into surrounding tissues and the bloodstream.
The metallic debris produced by metal-on-metal (MoM) hips can cause metallosis (metal poisoning).
Metallosis has been linked to side effects, including severe joint pain, difficulty walking, implant loosening, device failure, tissue death, deterioration of the bone around the implant, and cysts and pseudotumors. The patient eventually needs revision surgery to remove and replace the failed implant.
Revision surgery is often more difficult for the patient because of bone loss and damage. Recovery time is longer and the final results are often less successful than the original surgery.
Legal Troubles for Stryker
Stryker, like other manufacturers of metal-on-metal hips, faces lawsuits alleging the hips should have been subjected to rigorous testing before they were allowed on the market. But under current Food and Drug Administration (FDA) device clearance procedures, manufacturers were able to bring many metal-on-metal hips to market under a streamlined approval process.
If the manufacturer claims the device is substantially equivalent to a device already on the market, the company could avoid preapproval clinical testing requirements. Critics of the process say all devices should undergo testing because even seemingly minor differences in materials and design can have a major effect on a device’s safety and effectiveness.
This is not the first instance of legal difficulties for a Stryker metal hip. In 2012, the FDA issued a recall for the Stryker Rejuvenate and ABG II model hip implants. Patients who received those devices have reported debilitating pain, crippling tissue and muscle damage, and premature failure of their hip replacement.
Stryker Corporation has paid out more than $1 billion in settlement payments to patients harmed by Rejuvenate or ABG II devices.