What Is the DePuy ASR Acetabular System?
The DePuy ASR Acetabular System was introduced in 2005. Like many of the DePuy hip replacement products, the ASR Acetabular system was designed with metal-on-metal construction. Metal-on-metal devices were intended to be longer-lasting and more stable, resulting in a decreased failure rate due to solid construction. The ASR Acetabular System was designed to also provide increased mobility for younger patients with an active lifestyle.
Why Was the Metal-on-Metal Construction Preferred?
In addition to providing longer-lasting and more stable hip replacements, hip replacement systems with metal-on-metal construction were believed to not “wear out” as easily. It was also believed that these metal systems would not shed plastic fragments into surrounding tissue as other devices did.
Did Metal-on-Metal Systems Cause Problems?
The metal-on-metal construction turned out to be dangerous to patients due to the chance that the metals will grate against one another and release metal fragments into the surrounding tissue. The alloy used in the ASR devices is comprised of chromium, cobalt, and molybdenum. This can be toxic to tissues.
What Company Manufactures the DePuy ASR Acetabular System?
The DePuy ASR Acetabular System is manufactured by DePuy Orthopaedics, a company that is a division of Johnson & Johnson, the largest pharmaceutical and healthcare products company in the world. DePuy has an estimated annual revenue of $8 billion, while Johnson & Johnson’s annual revenue is $72 billion.
DePuy has created and manufactured over 200 surgical and medical device products, most of which have been successful. The ASR Acetabular System is not the only DePuy product that has been unsuccessful. Unfortunately, three DePuy products have caused serious medical injuries and resulted in thousands of lawsuits.
Is the DePuy ASR Acetabular System FDA Approved?
The DePuy ASR Acetabular System gained FDA approval in 2005 through the Food and Drug Administration’s (FDA) medical device exemption process known as the 510(k) Premarket notification clearance. The 510(k) process allows device manufacturers to apply for approval for a product that is similar to an already approved device on the market. Because of this exemption, the DePuy ASR Acetabular System had never been tested in humans before being marketed for public use, though DePuy claimed on information websites that the device “was thoroughly tested.”
When Were Adverse Events Caused by the DePuy ASR Acetabular System Reported?
In 2007, a British orthopedic surgeon presented information at a professional conference regarding his concern about failures but the company claimed that the high rate of complications was due to surgical technique. Information from a U.K. joint registry indicated that a large percentage of patients may experience failure of the device within 5 years, rather than the 15 years the devices were intended to last. DePuy was warned 7 times by the Australian health authority between 2007 and 2009. However, due to the lack of communication between medical agencies from country to country, the information was not highly publicized.
Was There a DePuy ASR Acetabular System Recall?
By 2008, just three years after the approval of the DePuy ASR Acetabular System, the FDA had already received over 300 severe adverse event reports regarding complications caused by the ASR hip system. In 2009, DePuy voluntarily pulled the ASR resurfacing from the Australian market but made no changes and continued to sell the device in the U.S. DePuy later issued a voluntary recall of all the ASR devices in August of 2010 but has not admitted fault. An internal review of the 510(k) process has uncovered flaws within the system, and the agency was prompted to review the system, though no significant changes have yet taken place.
Why Would Someone Need a Hip Replacement?
Hip replacements are typically necessary when the hip joint has been damaged or worn out to such an extent that it impacts mobility and can cause you pain, even when you’re not moving. Most commonly, osteoarthritis is the reason for a hip replacement. Osteonecrosis and rheumatoid arthritis also commonly necessitate hip replacement surgery.
Generally, you might need a hip replacement if any of the following are true:
- You experience persistent pain despite taking pain medication
- Your pain interferes with your ability to sleep
- Your pain affects your ability to walk either up or down the stairs
- Your pain makes it hard for you to stand up from a seated position
- Your pain is worse when you walk, even if you use a walker or a cane
What Is Osteoarthritis?
Osteoarthritis is a type of arthritis that causes damage to the cartilage that exists in between the bonds of a joint and helps to cushion the joint as you move. As this protective cartilage wears down, the bones can rub against each other, causing pain. Osteoarthritis can affect any joint but usually occurs in the hips, spine, knees, and hands.
What Are the Symptoms of Osteoarthritis?
The symptoms of osteoarthritis include:
- A grating sensation
- Bone spurs
- A loss of flexibility
What Are the Risk Factors of Osteoarthritis?
The following factors can increase the risk of developing osteoarthritis:
- Bone deformities
- Repeated stress on the joint
- Injury to the joint
- Older age
- Being female
- Other metabolic disorders
What Is Rheumatoid Arthritis?
Rheumatoid arthritis is a type of arthritis that occurs when your immune system mistakenly attacks your joints’ lining. This causes your joints to swell and, eventually can result in deformities in the joints and erosion of the bone. Doctors don’t know exactly what makes the immune system attack the lining of the joints but believe that genetics may cause certain people to be more susceptible to an environmental factor like a virus or bacteria that then could trigger the immune system.
What Are the Symptoms of Rheumatoid Arthritis?
The symptoms of rheumatoid arthritis include:
- Swollen joints
- Tender joints
- Warm joints
- Loss of appetite
- Joint stiffness, particularly:
- Following periods of inactivity
- In the morning
What Are the Risk Factors of Rheumatoid Arthritis?
The factors that could increase the risk of developing rheumatoid arthritis include:
- Being female
- Older age
- Family history
What Is Osteonecrosis?
Osteonecrosis, also called avascular necrosis, occurs when bone tissue dies due to a lack of blood supply. This causes the bones to collapse because tiny breaks form in them. Osteonecrosis can occur when a dislocated joint or a broken bone blocks off the blood supply to a certain section of bone. You can also develop osteonecrosis if you both drink alcohol and take medications with a high dose of steroids over a long period of time.
What Are the Symptoms of Osteonecrosis?
Many people don’t have any symptoms at all in the earlier stages of the condition. Eventually, you would start to feel pain, at first only when putting weight on the joint that was affected. Gradually, however, the pain would worsen and you would feel it even when resting.
What Are the Risk Factors of Osteonecrosis?
The factors that can increase the risk of developing osteonecrosis can include:
- Use of steroids
- Consuming too much alcohol
- Use of bisphosphonates
- Radiation therapy to treat cancer
- Organ transplant
What Are DePuy ASR Acetabular System Side Effects?
Many of the problems caused by the ASR Acetabular device are a result of the MoM construction and the release of metallic debris into the surrounding tissue. Other patients have experienced joint or device loosening and dislocation. In addition, many of the devices have failed due to dislocation and destabilization. Some experts believe that the Acetabular cup is too shallow and that this has caused some of the physical failures. Some of these side effects are severe and may be permanently disabling.
What Are DePuy ASR Acetabular System Severe Side Effects?
After undergoing a hip replacement that utilized the DePuy ASR Acetabular System, patients may experience severe side effects. These symptoms and severe side effects include:
- Loosening of the device components resulting in instability and joint detachment
- Metal poisoning or metallosis due to the shedding of fragments or metal ions
- Necrosis or death and dissolution of bone and surrounding tissue
- Increased blood levels of cobalt and chromium due to the absorption of metal ions
- Fracture of bones surrounding the implant
Patients may experience significant pain, inflammation, and impaired mobility due to failure.
Have Revision Surgeries Been Necessary After Hip Replacement with the DePuy ASR Acetabular System?
Many patients have been required to undergo revision or reconstructive surgeries to replace the device and repair damage to bones caused by the devices. In many cases, the revision surgery is much more painful and requires a much longer recovery time and some patients have become permanently injured due to metal-on-metal devices such as the ASR Acetabular System.
Are There DePuy ASR Acetabular System Lawsuits?
Over 90 thousand ASR devices were implanted worldwide and up to 40 percent of those devices may fail within the first five years after implantation. Over 10,000 lawsuits have been filed against DePuy for ASR Acetabular injuries.
Where Are the DePuy ASR Acetabular System Lawsuits Filed?
The first ASR Acetabular System lawsuit was filed in California. Multi-district litigation (MDL) was organized in the U.S. District Court for the Northern District of Ohio regarding more than 8,000 federal lawsuits but many more have been filed in state and local courts.
What Are the DePuy ASR Acetabular System Lawsuit Claims?
Because the lawsuits against DePuy and Johnson and Johnson all center around defective devices that caused injury, the lawsuits for injuries caused by the ASR Acetabular System involve product liability claims. Essentially, these lawsuits allege that DePuy and/or Johnson and Johnson:
- Manufactured a defective hip replacement device,
- Knew that the hip replacement device was defective, and
- Did nothing about the defective device and continued to let it be used in patients.
Has DePuy or Johnson and Johnson Settled Any DePuy ASR Acetabular System Lawsuits?
The first lawsuit that was filed in California resulted in an $8.3 million judgment in 2013. DePuy’s parent company, Johnson & Johnson agreed to settle the federal cases for $2.5 billion and has begun payments. There are still several hundred DePuy ASR Acetabular System lawsuits that are pending and have not been settled.
How Do I Find a DePuy ASR Acetabular System Lawsuit Attorney?
If you or a loved one underwent a hip replacement that used the DePuy ASR Acetabular System and experienced serious side effects or complications, you may be entitled to compensation. The attorneys at Seeger Weiss, LLP, have experience in this field and can consult with you regarding your case.
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