DePuy ATTUNE Knee System
Truth: Medical experts say that the ATTUNE Knee System has an “unusually high rate of early failure” compared to its competitors, which is widely attributed to the loosening of a defective baseplate.
Truth: Some sources claim that there is currently an excess of 1,400 FDA reports of ATTUNE Knee issues, with more than 600 of those patients requiring a second, riskier, and more painful revision surgery.
Truth: In the past decade, the manufacturer has faced roughly 500 FDA recalls, more than 10,000 lawsuits, and has paid billions of dollars to injured patients for defective hip and knee implant devices.
There’s growing evidence pointing to a high rate of failure in the ATTUNE Knee System. However, instead of voluntarily recalling the baseplate that medical and legal experts are calling defective, DePuy Synthes has quietly released a new baseplate alongside the existing one. This suggests that the company is aware that the original baseplate was prone to complications.
Looking at the company’s long history of recalled products and legal trouble in the medical device industry, this suggests a pattern instead of an exception. Many believe that DePuy Synthes and Johnson & Johnson put profits before people.
If you believe that you’ve suffered from a defective ATTUNE Knee implant, contact us now to see how you can fight back.
What Is the ATTUNE Knee System?
The DePuy ATTUNE Knee System was designed for total knee arthroplasty (TKA), or total knee replacement, in which all the weight-bearing surfaces in the knee joint are replaced. DePuy touts the device as innovative and state-of-the-art, offering superior movement and stability compared to its competitors.
According to the DePuy Synthes, more than 575,000 systems have been implanted worldwide as of late 2018.
The system received the Food and Drug Administration’s (FDA) 510(k) Premarket Notification in 2010. Often referred to as “fast-track” approval, this meant DePuy was able to show the FDA that ATTUNE Knee was “substantially similar” to current knee replacement products on the market.
As a result, DePuy wasn’t required to run clinical trials to prove the system’s safety and effectiveness.
However, mounting evidence is showing reason to question its safety. As of mid-2017, sources say that the FDA had received roughly 1,400 reports of the ATTUNE Knee system failure, with more than 600 of these patients undergoing revision surgery to fix complications.
How Does Knee Replacement Surgery Work?
In a knee replacement surgery, damaged cartilage and bone is removed from the following three areas of the patient’s knee area:
- Patella (kneecap)
- Tibia (shinbone)
- Femur (thigh bone)
These parts are then replaced with a prosthesis, or artificial joint, that’s typically made of metal alloys, polymers, and high-grade plastics. Typically, metal implants are attached to the ends of the femur and tibia. Then, a plastic spacer is placed between the metal implants to mimic the cartilage of a healthy knee.
Who Is a Candidate for ATTUNE Knee?
Knee replacement surgery is most commonly performed on patients over age 45 who suffer osteoarthritis, which causes “wear-and-tear” of the cartilage that protects the bones in the knee. Other reasons for knee replacement surgery include psoriatic arthritis and rheumatoid arthritis.
It’s also performed on patients who have experienced injuries like broken bones or torn ligaments, as well as those with deformities like bowed legs or “knock knees.” Patients are considered bowlegged when, while standing with feet together, their ankles touch but their knees don’t. “Knock knees” are the opposite, where the knees touch but the ankles don’t.
Prior to surgery, knee replacement patients typically experience severe knee pain, especially when performing everyday activities like walking, sitting and standing, and climbing stairs.
What Are the Risks of Using ATTUNE Knee?
A 2017 article in The Journal of Knee Surgery described the ATTUNE Knee System as having an “unusually high rate of early failure” as compared to similar products. The article examined 15 hospital-reported cases of tibial loosening, and 21 cases from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
While typical knee replacements are estimated to last between 12 and 20 years, many reports indicate that ATTUNE Knee has failed within two years. Some reports state that the implant has failed in as little as a few months.
Many ATTUNE Knee patients have reported side effects and warning signs of failure including:
|Chronic pain: persistent pain or throbbing sensations, especially when the knee is actively in motion||Tissue, nerve, or bone damage: failed implants can destabilize and damage the entire knee region|
|Instability: a wobbly feeling, difficulty walking, or trouble moving between standing and sitting positions||Swelling: typically caused by inflamed knee lining, which can cause a fluid buildup around the implant|
|Abnormal warmth: while it’s normal to be warm after the surgery, persistent warmth can indicate infection or failure||Popping and clicking sounds: these noises heard while the knee is moving are a classic sign that the implant is out of place|
ATTUNE Knee’s Major Defect: Tibial Loosening
The most commonly-reported issue involves the area where the device connects to the top of the patient’s tibia, or shinbone. Some experts suggest that the cement is defective, failing to hold together the implant’s tibial baseplate and the patient’s tibia.
Others suggest that the surface of the tibial baseplate is too smooth for the cement to properly stick, as it’s significantly smoother than similar products on the market.
Whichever component is the cause, many patients and their doctors have reported that the bond between the tibial baseplate and tibia loosens, which then destabilizes the entire system. As a result of this tibial aseptic loosening, or loosening without any infection, patients may experience unbearable pain or loss of function.
When this occurs, the patient must undergo complex and invasive revision surgery.
Issues Identifying Tibial Loosening
While there are hundreds of existing reports of tibial loosening issues, medical experts fear that this issue may be underdiagnosed.
The authors of the above The Journal of Knee Surgery article also wrote that improper bonding is “markedly underreported.” This is due to the difficult nature of identifying loosening via X-rays, causing the issue to go unnoticed during standard checkups.
Patients who don’t receive immediate treatment for tibial loosening may experience more serious complications like bone loss, fractures, or tissue and nerve damage.
DePuy’s New Tibial Baseplate
In early 2017, DePuy released a new fixed bearing tibial baseplate marketed with new “ATTUNE S+™ Technology.” A product brochure states:
“DePuy Synthes sought to develop a stronger understanding of the causes of aseptic loosening.”
This new development came after several reports of tibial loosening in the original system. Legal experts spearheading several lawsuits against Johnson & Johnson and DePuy suggest that this isn’t far from an admission of guilt that the original system was flawed.
Injured patients and their loved ones are outraged that this updated baseplate was released without any recall or public recognition of the previous baseplate’s reported issues.
Revision Surgery Risks
The only way to fix a knee replacement failure is to replace some or all components of the original implant. This is done by undergoing a revision surgery, which is also called correction surgery.
Unfortunately, revision surgery’s success rates are much lower than initial total knee replacement surgery. These procedures often require longer recovery periods and present more dangerous long-term risks for the patient.
Revision surgery risks include:
- Bone fracture during the operation
- Nerve or blood vessel damage
- Long-term knee stiffness
- Reduced range of motion
- Blood clots, including pulmonary embolism (lung blood clot)
- Improper healing or infection of the surgical site
- Other medical issues, such as lung complications, heart attack, or stroke
In many cases, the revision surgery is more complicated and painful than the original surgery.
This is escalated when patients experience bone loss from the implant’s failure.
Revision Surgery after Bone Loss
When bone loss occurs, the surrounding bone may need to be rebuilt using augments, or metal pieces that act as missing bone substitute. Another option is a bone graft, which uses transplanted bone from other areas of the patient’s body, such as their legs, hips, or ribs.
These revision surgeries often require more specialized implants than standard knee replacement systems. In addition to compensating for bone loss, patients may need extra support in the form of implants with thicker and longer stems, which can fit deeper into the bone.
ATTUNE Knee Lawsuits
It’s believed that there are hundreds of ATTUNE Knee lawsuits in progress, with the first filed in late 2017. Legal experts suggest that the lawsuits will likely be consolidated into a multidistrict litigation (MDL) case, with a federal district court overseeing several groups of cases.
Among the issues for which Johnson & Johnson and DePuy are being sued include:
- Negligence, or failure to take proper care in ensuring patient safety
- Inadequately warning patients of complications and potential harm
- Breach of express and implied warranty, meaning that the patients felt misled in the manufacturer’s claims of safety and effectiveness
- Negligent misrepresentation, or failing to disclose that the ATTUNE Knee system may not have been as safe as originally advertised
- Fraud, or deliberate deception and concealing critical information in the interest of earning more sales despite safety issues
- Loss of consortium, filed on behalf of the patient’s spouse or family members, which claims that the individual suffered a loss in the quality of the relationship due to the patient’s injury
DePuy’s History of Regulatory and Legal Trouble
The following list highlights a rough and abridged timeline of some key regulatory and legal events. These events primarily involve three of Johnson & Johnson and DePuy’s medical implant devices: the ASR Hip System, PINNACLE Hip System, and ATTUNE Knee System.
2010 – 2013: DePuy recalled 277 knee implant systems and various system components due to loosening and premature failure. These recalls involved the DePuy Limb Preservation System (LPS) and SIGMA Knee System.
2010: DePuy recalled its metal-on-metal ASR Hip implants due to high failure rates. More than 9,000 injured patients filed a lawsuit against the company.
2013: DePuy paid $2.5 billion to settle thousands of claims from injured ASR Hip patients. The company reached an agreement to establish a claim settlement program.
2015: DePuy recalled nearly 3,500 units of its ATTUNE Knee Tibial Articulation Surface component. The component featured a spring coil that could break off and become lodged in the patient’s knee. This recall was terminated by the FDA roughly four months after the recall was posted.
March 2016: Johnson & Johnson and DePuy were ordered to pay $150 million (reduced from $500 million) in damages to five Texas plaintiffs who were harmed by DePuy’s PINNACLE Hip System. This system faced more than 9,700 lawsuits across the United States.
November 2016: An additional six plaintiffs in California were awarded $543 million (reduced from $1 billion) over the PINNACLE Hip System.
September 2017: It’s believed that the first lawsuit over the ATTUNE Knee System’s premature failure was filed in Alabama.
November 2017: Johnson & Johnson and DePuy were ordered to pay $274 million in damages to six New York plaintiffs for the PINNACLE Hip System.
December 2017 and onward: Dozens (possibly hundreds) of additional ATTUNE Knee lawsuits have been filed.
Do I Have an ATTUNE Knee Case?
If you received an ATTUNE Knee replacement that has led to severe pain and suffering and the need for a complicated revision surgery, you may have a case.
You and your family may be able to receive financial compensation for medical bills, lost wages from missed work, and the physical and psychological pain you’ve experienced from the ordeal.
We specialize in complex medical litigation, and our team is dedicated to fighting for your justice. We won’t sit idly by while Johnson & Johnson and DePuy continue to reap billions of dollars in profits at the expense of their customers.
Contact us now to get started on your case.