Artificial knees can help alleviate pain, enhance knee function, and improve quality of life when they work as they should. But some of the artificial knee devices on the market have been associated with instability, pain, range of movement issues, premature failures, and additional unplanned revision surgeries. Patients who suffered from these complications and adverse events are seeking answers and justice. Some may be eligible for significant financial redress for their injuries and losses. Contact us today to learn more about the laws that protect patients from defective medical devices and whether you are eligible for significant financial compensation.
DePuy’s Attune Knee System
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More than 500,000 people will have a knee replacement surgery this year alone in the United States, and estimates show that since the early 1970s when artificial knees became available nearly 5 million have received knee implants. Patients generally have one or both knees replaced due to injury or degenerative disease such as rheumatoid arthritis, but only after other treatment measures have failed, such as treatment with medicines and injections, lifestyle changes, and physical therapy and rehabilitation.
The Attune Knee System, manufactured by DePuy Synthes Joint Reconstruction, a unit of Johnson & Johnson, is marketed and promoted as having certain proprietary technologies that improve range of motion and stability. Unfortunately, hundreds of reports of failures and malfunction have been filed, including reports of:
- Device loosening
- Cracked and broken components
- Bone and device fractures
Not only have patients been forced to undergo additional unplanned surgeries to remove the device, some patients reportedly underwent multiple revision surgeries on the same knee. In fact, more than 500 reports of failures, malfunctions, and revision surgeries have been filed with the FDA’s MAUDE database since the beginning of 2018 alone.
Artificial Knee Failure Symptoms
Patients who undergo a total knee replacement can expect to endure a two- to three-hour surgery followed by several days in the hospital. Your doctors will order rehabilitation therapy to start immediately with the goal of strengthening the muscles and tendons that were manipulated and cut during surgery and improving your range of motion.
For the first three to six weeks after surgery, your activities will be restricted, while you concentrate on recovery. Once you are released for normal activities, you will still have limitations. High-impact activities and sports like running and football will need to be avoided for the rest of your life, but you will be encouraged to engage in low-impact activities such as bicycling, walking, and swimming.
And while most artificial knees will continue to function normally for 15 years or longer, the Attune knee system has reportedly failed within two years, forcing patients to have unplanned surgeries to repair damage and replace the device. Some particularly unfortunate malfunctions and failures have caused some patients to have more than one revision surgery. Because of the high incidence of premature failure, any patient who received an Attune knee should be familiar with the symptoms that may occur if their device has loosened, broke, or otherwise failed:
- Bone fractures around the implant
- Decreased range of motion
- Dislocation or loosening of the device
- Heat and redness surrounding the knee joint
- Infection deep within the joint or surrounding the implant
- Inflammation and swelling of the knee joint after you have fully recovered
- Instability or a knee that shifts backward, forward, or sideways upon standing
- Localized muscle or nerve damage
- Throbbing pain when you move the knee
If you experience any of these symptoms after receiving an Attune Knee System, make an appointment to have your implant assessed. Patients whose knee implants failed or malfunctioned can call us anytime day or night to learn more about these failures, laws that protect patients, and whether they qualify to seek compensation.
Attune Knee Associated with High Failure Rates
Researchers have reported an unusually high rate of premature failures in the Journal of Knee Surgery. Nine orthopedic surgeons noted the high failure rate and reported that some patients experienced failures within 24 months of implantation. The authors researched the databases of three hospitals and found 15 patients who had to endure revision surgery after receiving the Attune knee. They discovered that each of the knees that had been explanted had become loose, and none had retained the cement bond between the device baseplate and the leg bone.
In the article, the authors suggest several potential causes of premature Attune knee failures:
- Increased constraint
- Reduced cement pockets
- Reduced keel rotational stabilizers
- Inadequate surface roughness
The authors also suggest that loss of the cement bond be considered any time an Attune patient experiences knee joint pain as they believe the incidence of tibial failures is likely underreported because of several factors, including that revision data from other manufacturers are not included in Attune MAUDE database reports, and because of a lack of radiograph assessments.
Researchers in a separate study concluded that high-viscosity cement could be at the center of premature failures due to loosening. In a study published in the Journal of Arthroplasty, authors suggest disbonding be investigated when patients present with pain and loosening, and infection tests are negative.
Attune and its History of Recalls
Attune has a history of issues as evidenced by repeated recalls for various problems. In fact, recalls were issued in 2012, 2014, 2015 and 2018. The Class 2 recall issued in 2015 involved thousands of Attune knee devices from which a small wire coil could separate. If unnoticed by surgeons, the coil could remain in the patient. The other recalls were issued for things like burs on the threads of extraction holes, problems with packaging, pin bushing overloads, and breakage of extraction handles.
Part of the issue with the Attune knee could be that it was approved through the 510(k) premarket approval process, a controversial program that allows medical devices to reach the market faster than traditional approvals because it requires far less safety data. Traditional premarket approvals require device manufacturers to conduct multiple, large clinical trials that show the effectiveness and safety of the device. But to get approval through the 510(k) process, device manufacturers are required to show a bare minimum of safety data and that their device is substantially similar to another device that has already been approved for the market (called a predicate device).
This means that even though DePuy marketed, advertised, and promoted the Attune knee as one with proprietary technologies that set it above the rest, what the company showed the FDA was that Attune was substantially similar to devices already on the market.
Unfortunately, the predicate devices that DePuy showed Attune was substantially similar too had problems of their own. DePuy claimed their device was similar to the:
But two of these predicate devices were recalled from the market for malfunctions and failures. Zimmer is facing lawsuits from across the country filed on behalf of patients who sustained serious injury from the NexGen knee. But the FDA does not consider the recall or safety history of a predicate device when it approves a new device through the 510(k) process.
Attune Knee Replacement Lawsuits
Lawsuits are being filed on behalf of patients who were forced to undergo one or more revision surgeries because their Attune knee prematurely failed, caused them to suffer pain and debilitation, and forced them to have to have additional, unplanned surgeries to have the device replaced.
One recent lawsuit alleges the Attune knee is failing at unprecedented rates due to mechanical loosening, was defectively designed, is not effective, is more dangerous than other knee implant devices available on the market and increases a patient’s risk of serious injury. The lawsuit alleges Attune manufacturer DePuy failed to warn doctors, surgeons, and patients of these risks and dangers of the device or that it may fail within a short time of being implanted.
Lawsuits will continue to mount against DePuy as the thousands of patients who were implanted with the device experience issues, premature failures, and unplanned surgeries. Some experts have suggested that multidistrict litigation may need to be established to handle the number of lawsuits expected to be filed.
We Can Help
Did you know that device makers have a high duty to ensure their products are safe and effective for use as directed? When they fail their duty, they may be held liable for injuries and losses caused by their products. Patients may not know that they have the power to hold device makers accountable for failing their duty, even if the device maker is a pharmaceutical giant.
Patients who suffer pain, infection, device loosening or premature failure resulting in the need to undergo one or more revision surgeries may be entitled to seek justice and significant compensation for their injuries and the losses sustained because of those injuries. Our attorneys have been helping patients hold device manufacturers accountable for harms their products cause, and we can help you too. Contact us today to learn more about what we can do for you.