DePuy Attune Knee: Loosening and Debonding Risks
Knee replacement surgeries have been performed since the 1960s, and today are considered a highly effective treatment of degenerative joint disease or arthritis. Knee replacements are among the most successful surgical procedures in medicine, and their survival rates are reported to be more than 90% at 10-19 years of follow-up.
With an aging population, the number of knee replacement surgeries is expected to grow. As a result medical device manufacturers are continuously trying to develop new and better knee replacement technologies.
In 2013 DePuy Synthes (a Johnson & Johnson company) began marketing what they billed as “a knee that can help patients get back sooner.” The Attune knee system, the manufacturer claimed, was a novel new design and the result of “one of largest research and development projects in the history of DePuy Synthes Joint Reconstruction.” It offered patients “the latest in design, kinematics, engineering and materials to deliver stability and motion.” All resulting in increased range of motion and a shorter hospital stay.
DePuy’s marketing campaigns were highly successful, and orthopedic surgeons began to implant the Attune knee into patients by the thousands.
Within a short period of one to two years, however, “an unusually high” number of Attune knee patients began to complain of severe pain with their new knee. Many required additional surgeries to try to correct the problems. Subsequent surgeries to replace the Attune knee can often be more invasive than the initial surgery and require an even longer recovery time.
If you or a loved one has experienced complications from knee replacement surgery with the DePuy Synthes Attune knee system, including loosening or debonding of the tibial component, contact us right away or call 1-866-900-7078 for a free case evaluation. You may be eligible for compensation.
With so much “research” and “the latest in design” and technology, why were Attune knee patients returning to their doctors within two years to replace the replacement, when knee replacements are supposed to last upwards of 20 years?
DePuy Attune Knee – The Problems
The primary problem with the Attune knee is tibial debonding or loosening. Tibial loosening occurs when the Attune plate, which is attached to one of the lower leg bones, comes loose. In the Attune knee, a cement is used to bond the plate to the tibia. Unlike other knee replacement systems, the Attune plate is too smooth for the glue to adhere it to the bone, causing detachment, which can happen as soon as one to two years after surgery.
Loosening of the Attune knee can lead to instability or dislocation, severe pain, fractured bones, muscle damage, nerve damage, infection, and usually requires replacement surgery.
Another noted defect is the potential for the Attune components or the surrounding bone to fracture.
Detachment can be so painful that many Attune knee patients have had to have additional surgeries to try to fix the issue. These subsequent knee surgeries can often be more invasive than the initial knee replacement surgery and can potentially lead to longer recovery time.
The Facts: DePuy Attune Knee Implant
- The DePuy Attune knee implant was launched into the U.S. marketplace in 2013, and it has since been used in more than 100,000 patients.
- A 2017 study published in The Journal of Knee Surgery concluded that Attune knees had an “unusually high” early failure rate, with more than 230 reports to the FDA regarding Attune tibial loosening. The study suggested that the problem was a failure of the cement to bond the implant to the bone, and that the defect might be an underreported problem with Attune knees, because it is difficult to detect with X-rays.
- The online magazine Orthopedic Design and Technology reported that by 2017 DePuy, itself, had begun to file reports with the FDA documenting premature failures of the Attune knee system that had resulted in the destabilization of patients’ knee replacements. According to the article, these failures almost always require more invasive and painful revision surgery to remove the implant and replace it.
- In 2017, the first lawsuit was filed against DePuy Synthes for knee replacement failures.
Attune Knee Cleared Without Clinical Trials
Unlike pharmaceuticals, the majority of medical devices in the United States are cleared by the FDA for marketing without having to have undergone clinical trial testing.
An FDA approval process known as 510(k) allows manufacturers to register their “new” device if they are able to prove that the device is “substantially similar” to another device that did go through clinical trial testing and the FDA approval process.
The 510(k) system of approval was introduced in the 1980s. Since that approval process has been instituted, there have been more and more medical device failures and recalls. A 2017 Journal of Healthcare Finance study concluded that the 510(k) process is not as safe to the consumer as once thought. On behalf of public safety, the study recommends more clinical trials and performance data:
“Congress and the FDA need to take action now to change the regulatory structure that guides medical device review. They must require the inclusion of more clinical use performance data, including postmarketing reporting and a national registry…. These changes will provide the assurance of safety and effectiveness in devices currently lacking in the 510(k) review and ultimately mitigate the risk to consumers…”
Signs Your DePuy Attune Knee Implant May Be Failing
Physicians have reported hundreds of cases of Attune failures. Some suspect there may be thousands more who may go undiagnosed because the defect does not show up clearly on X-rays. If you received a DePuy Attune knee implant and are experiencing any of the following symptoms, your implant may have loosened:
- Chronic pain
- Backward or sideways movement in the knee
- Instability when putting weight on the Attune knee
- Decreased range of motion
- Swelling or inflammation
- Unusual warmth around the knee months after surgery
Personal Injury Lawyers Evaluate Attune Knee Replacement Claims – Free
We are currently investigating cases involving early knee implant failure with the Attune knee.
If you or a loved one has experienced complications from knee replacement surgery with the DePuy Synthes Attune knee system, including loosening or debonding of the tibial component, you may be eligible for compensation.