The numerous recalls of hip implants over the years in the US were due to a high rate of failure and injury to patients.
“Metal-on-metal” wear and tear is a common cause of failure, as the metal components of the implant rub against each other, releasing metallic debris into the surrounding tissue and causing inflammation, pain, and potential damage to muscles, bones, and nerves.
Do you suspect you need revision surgery due to a defective hip implant? The personal injury attorneys at Rosenfeld Injury Lawyers, LLC, are advocates for injured patients harmed by defective medical devices.
Contact defective medical device lawyers at (888) 424-5757 to schedule a free consultation and discuss your legal options for initiating a hip implant case. We have experience with Stryker hip replacement lawsuits.
ABG II and Rejuvenate Devices
The FDA approved the ABG hip implant without human studies or clinical trial data. The company had already been hit with multiple hip replacement lawsuits over faulty products.
Thousands of patients suffered harm because of defective implants. But the agency didn’t require Stryker Orthopaedics to do anything except submit the paperwork required to file the application.
In 2017, the company recalled the product. Then, in February 2018, it announced another recall. And now, the FDA has approved the second version of the device.
Hip Replacement Implant and the FDA
The Stryker hip implant should never make it to market. The FDA should not approve medical devices without requiring companies to conduct rigorous testing.
Unfortunately, the agency doesn’t always take this approach. Instead, it approves devices based on what it thinks are reasonable assumptions about how well the technology works.
Were Stryker Rejuvenate Hip Replacement Systems Recalled?
Metal-on-metal Stryker hip replacement systems have been recalled because they are associated with increased risks of complications, including:
- Blood clots
The Stryker rejuvenate hip implant recall affects about 30,000 patients.
The defective hip implant problem stems from metal particles left behind during manufacturing. They can cause serious injury to patients, even if the implants function properly.
In 2018, the FDA announced it was investigating Stryker over concerns about the device’s safety. Stryker agreed to pay $1 million to settle allegations that it failed to report data that showed the devices could fail prematurely.
Stryker Hip Replacement Recalls
Stryker hip replacements have been one of the most significant medical devices recalls in recent history. It was the largest product recall ever recorded by the FDA. As of November 2018, there are over 7,500 reports of complications related to the implants.
According to the latest data, there have already been nearly 2,300 reported cases of adverse events linked to faulty hip implants.
Several lawsuits were filed against Stryker, alleging that the company failed to warn consumers about potential risks associated with the defective implant devices.
Claims reveal that Stryker did not properly disclose information regarding the risk of dislocation and revision surgery.
Stryker Hip Injuries & Device Recall
The medical device maker Stryker Corp. announced a voluntary recall of its Rejuvenate and Abb II hip implants after receiving reports of device failure. Approximately 50,000 patients were affected by defective devices and needed revision surgery.
LFIT V40 Femoral Head Settlement
The maker of orthopedic Stryker hip replacement devices, including the LFIT V40 femoral head, announced it reached a settlement agreement in a Minnesota federal court with approximately 500 plaintiffs representing nearly 2,500 claims.
Under the terms of the global settlement, Stryker will pay $75 million to resolve allegations related to the LFIT V40 hip stem system. The Stryker modular hip settlement resolves claims against Stryker involving the LFIT V40 and includes both class action and individual lawsuits.
The Rejuvenate and ABG II $2 Billion Settlement
Stryker Orthopaedic Products, LLC announced it had agreed to settle all remaining product liability litigation stemming from its Rejuvenate and ABG II hip implant systems. As part of the settlement, Stryker paid $2 billion to resolve all claims regarding the products.
The Rejuvenate system consists of three components: the femoral head component, the acetabular cup component, and the polyethylene liner. The ABG II hip system includes four components:
- Femoral stem component
- Acetabulum component
- Polyethylene insert component
- Metal shell component
In addition to paying the $2 billion, Stryker agreed to provide free Rejuvenate and AB -G II replacement parts to patients who qualify under certain conditions. Under the settlement terms, eligible patients must submit a claim form within 180 days of receiving the recall notice.
Serious Complications with the Company’s Tritanium Acetabular Shells
Patients who file a claim form will receive reimbursement for medical expenses associated with the treatment of complications arising from using the recalled devices.
Filed complaints allege that the Rejuvenate and AB –G II hip implants caused serious injuries, including:
- Nerve damage
- Heart attack
These allegations include those relating to both primary and revision surgeries.
More than 80 lawsuits are still ongoing in state and federal courts, with lawyers investigating complications related to Rejuvenate and ABG II hip implants.
The Stryker Hip Recall Settlement
The Stryker hip recall involves two different implant systems: the Stryker ABG II and the Rejuvenate. These systems are used to replace patients’ hips. Nearly 17,000 patients had one of these implants placed during hip replacement surgery. About 2,500 people have been notified about the recall.
Patients who received either type of device will receive payment from the $1 billion settlement fund. The settlement includes both medical product companies and doctors who performed surgeries.
Common Symptoms of Patients Injured by Recalled Stryker Hip Implants
According to the FDA, metal debris and ion release are the number one concern of patients receiving these implants. They are now recalling these devices because of excessive wear and corrosion, which could lead to increased implant failure rates and infections.
Why Did Stryker Recall the Rejuvenate and ABG II Devices?
The Food & Drug Administration (FDA) announced a voluntary recall of the Rejuvenate and AbbVie Biomet Orthopedics (Stryker) ABG II hip replacement devices due to potential adverse reactions.
There are two main causes of adverse reactions: fretting, corrosion of metal alloys, and metallosis (metal toxicity). Fretting occurs when the implant rubs against itself over time, causing wear and tear and the release of metal ions around the hip joint.
Corrosion happens when the device corrodes over time. Metallosis is excessive metal debris in the knee joints, causing tissue damage.
Patients who are sensitive to metals may experience an allergic response requiring revisions. Excessively high levels of metallic debris in their knee joints can cause osteolysis or bone erosions.
Stryker’s Potentially Dangerous Hip Replacements
In 2010, Stryker became the world leader in orthopedic surgery when it acquired OrthoCarbone LLC, a medical technology company based out of West Palm Beach, Florida. The acquisition gave Stryker access to the market for artificial hips, one of the most common surgeries performed yearly.
The company’s first product was the ASR XL Acetabular System, which used a ceramic shell to replace the acetabulum bone socket in the pelvis during total hip replacement. This system was followed up with the ASR Hip Resurfacing System, which replaced the femoral head in the thighbone.
Both products were approved by the Food and Drug Administration (FDA). In 2012, the company recalled the ASR Hip Resurfacing System because of concerns over premature failure.
V40 Hip Implant System
Stryker Orthopedics introduced the V40 Hip Implant System, which used a titanium alloy shell to replace the acetabulums. The V40 Hip Implant was designed to help alleviate pain and improve mobility in patients suffering from osteoarthritis.
After the recall, the company continued selling the V40 Hip Implants, despite reports of fractures and dislocations among patients. In 2015, the company announced it would stop manufacturing the V40 Hip Implant altogether.
As of 2017, approximately 44,000 hip implants worldwide could pose health hazards to patients.
Stryker Hip Metal-on-Metal Construction
The recall has affected approximately 3 million units sold since April 2013, including the metal-on-metal Model 2200 Series and the Model 2300 Series. These models use metal-on-metal bearings, which are used in artificial joints. Stryker Corporation manufactures them.
Metal-on-metal hips are similar to other devices that have been recalled. There are many different kinds, so you must examine the device carefully before deciding.
Metal fragments and shedding cause problems in the hip area, they can also lead to systemic reactions, including:
- Abdominal pain
- Joint swelling
Stryker Hip Implant Complications
The metal hip replacement device, the Stryker Hip Implanter, caused complications such as infections, pain, revision surgeries, and even death.
Metal-on-metal devices like the Stryker hip implants cause severe problems, including infection and osteolysis, according to a report published in 2017 by the Institute for Safe Medication Practices.
These surgeries are required when the device fails. A study by the Mayo Clinic found that approximately one-third of patients receiving a metal hip implant required revision surgery within five years. Some underwent multiple surgeries due to serious complications, metal poisoning, and severe pain.
Stryker Hip Recall Timeline
In 2008, the Food & Drug Administration (FDA) approved the Rejuvenate Modular Neck Hip Implant System. In 2009, the agency approved the ABG II Modular Neck Hip Implanter System.
In 2010, Stryker issued an urgent field safety note to surgeons about possible risks related to the implants. In 2012, the company issued another warning about the potential risk of metal debris in surrounding tissue caused by the hip devices.
Stryker Revision Surgery on ABG II Modular-Neck or Rejuvenate Modular-Neck Hip Stem Systems
The recall announced affects certain models of the Rejuvenate and ABG II Modular Neck hip stems manufactured before June 30, 2013. These products are used during total hip replacement surgeries to help stabilize the femur bone in the hip joint. If the product fails, it could cause serious injury or death.
Patients who qualify for Stryker Rejuvenate and ABG II reimbursement under this settlement include those who underwent a revision procedure following the initial surgical implantation of the affected device. Eligible patients will receive up to $50,000 per hip implant.
This settlement program compensates eligible US customers for the costs of having the recalled devices removed and replaced with another one. Victims will be reimbursed based on the amount paid for the implants.
Hire a Personal Injury Lawyer to Resolve Your Hip Replacement Lawsuit
Contact our personal injury lawyers at Rosenfeld Injury Lawyers, LLC by calling (888) 424-5757 or use the contact form to schedule a free consultation to discuss filing a Stryker hip replacement lawsuit to recover compensation for your damages.
We accept all Stryker hip implant replacement lawsuits on a contingency fee agreement, meaning you will not pay upfront fees to see monetary recovery.
- About Hip Implant | Stryker
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