Early Failure of ATTUNE® Knee System? You May Be Entitled to Compensation
Since its first clinical use in 2011, the DePuy Synthes ATTUNE® Knee System has been implanted in more than 500,000 patients across the globe. At least 60,000 patients in the United States have been implanted after discovering they were in need of total knee replacement. While most knee replacements, on average, last approximately 20 years, patients and physicians are claiming that ATTUNE® devices are causing early failure resulting in pain, limited mobility, and the need for corrective surgery.
DePuy Synthes is a division of the Johnson & Johnson Family of Companies and its ATTUNE® Knee was backed by the company’s largest ever research and development effort. The system was designed to get patients back to their normal lives sooner after surgery.
A search of the U.S. Food & Drug Administration (FDA) MAUDE (Manufacturer and User Facility Device Experience) database found numerous reports of patients having problems with the ATTUNE® system. Findings show a high number of cases of debonding at the tibial implant—cement interface with symptoms typically appearing within two years of implantation of the knee system. This loosening of the implant has resulted in patients experiencing swelling of the knee due to excessive fluid, pain upon standing, and limited range of motion. Patient narratives include the following:
- “DePuy ATTUNE® knee implant is failing. Instability in my knee. Constant severe pain. Loss of mobility and strength. Knee gives out (even with a brace). Popping, clicking and clunking sounds. Knee is constantly warm to the touch.”
- “Total knee replacement never quit swelling, becomes inflamed under normal use, heats up, causes pain, feels unstable. Doctors suspect bad glue/cement allowing movement in lower portion. Could not return to work.”
- “I had an ATTUNE® DePuy knee replacement put into my left knee and I have had pain and stiffness ever since… This has ruined my life…”.
A research study reported in the June 2017 issue of The Journal of Knee Surgery concluded that there is an “unusually high rate of early failure” with the ATTUNE® system. Researchers reviewed three hospital databases and identified 15 cases where patients who received the ATTUNE® system presented with a debonding of the tibial apparatuses, and later required revision surgery. Of these 15 cases, only two had the loosening detected by radiographic evaluation. Thus, researchers were of the opinion that this complication may be underreported due to the failure of medical imaging to detect the problem.
The Downside of Knee Revision Surgery
Those who have experienced problems with the ATTUNE® knee system often require corrective surgery. This surgery removes all or part of the original implant and sometimes surrounding bone and tissue. Then, the original implant is replaced with a new implant. The operation is more complex than original total knee replacement surgery, requires the patient to be on the operating table longer, and results in longer recovery time. The danger of complications from the surgery is also greater. The American Academy of Orthopedic Surgeons lists possible risks:
- Poor wound healing
- Reduced range of motion or stiffness in the knee
- Infection in the wound or the new prosthesis
- Blood clots
- Bone fracture during surgery
- Damage to nerves of blood vessels
- Pulmonary embolism – a blood clot in the lungs
- Medical problems such as heart attack, lung complications, or stroke
Those who suffer these complications may find their lifestyles and health seriously compromised. In addition, large medical bills and an inability to work – either temporarily or permanently – can be devastating.
Attune Knee Replacement Device Prematurely Failing
The DePuy Synthes ATTUNE® total knee arthroplasty system was first introduced in 2010 and was designed to give more stability and improved range of motion compared to earlier knee replacement devices. However, reports of problems with the device resulting in injury to patients has been known and reported to the FDA for several years.
Reports of problems with the ATTUNE® device showed early failure of the device causing loosening of patients’ knee replacements and painful revision surgeries. In the 2017 study, nine prominent orthopedic surgeons stated that they have encountered an unusually high-rate of premature failures of the ATTUNE® knee system. The surgeons attributed the failures to tibial loosening, which occurs when the bone and the knee device come apart, resulting in destabilization to the entire knee replacement.
Your Legal Options
If you or a loved one have experienced problems with your ATTUNE® knee system implant, or have experienced serious complications from knee revision surgery as a result of failure of the original implant, you could be entitled to compensation.
Call us at (888) 458-6825 or fill out our contact form to discuss your legal options.
The consultation is free and confidential.