Over 700,000 knee replacement surgeries are done each year in the U.S., giving many people a renewed ability to live life to the fullest. The overwhelming percentage of knee replacements is successful and patients can expect a lifespan of 15 years or more.
Unfortunately, sometimes knee replacement devices fail due to a design or manufacturing defect. When a knee replacement goes bad, the only way to stop the resulting pain from illness, injury and other harm is to have costly and painful knee revision surgery.
The DePuy Attune Knee Replacement System is the most recent in a series of defective total knee replacements. It was recalled by the FDA in 2015 due to a high rate of early failure caused by a design defect. Two years after the recall there were 1,400 adverse effect reports filed with the FDA and 45% claimed knee revision surgery had to be performed.
What is wrong with DePuy’s Attune Total Knee Replacement?
As reports of the premature failure of the Attune knee replacement escalated, a team of nine highly qualified orthopedic surgeons conducted a study and published the results in The Journal of Knee Surgery. The team examined the clinical, X-ray and surgical findings of patients that received the Attune Knee replacement and had to undergo revision surgery to remove the faulty device and implant a new one.
These surgeons found that there was “an apparent loosening of the tibial component with gross implant motion between the tibial tray and tibial bone cement”. In other words, the cement holding the Attune implant in place does not stick to the tibial part of the Attune Knee System. This causes a loosening of the Attune device, making the entire system unstable.
What you should do if you have pain from a knee replacement.
Patients expect a certain amount of pain immediately following knee replacement surgery. Pain, discomfort and stiffness should gradually abate in the following months. If you are suffering from unusual pain after adequate recovery time, go back to your orthopedic surgeon for an exam. Don’t hesitate to get a second or even a third opinion if you are not satisfied because injuries and disease caused by a defective medical device can be irreversible.
You should also investigate any recalls, alerts or complaints regarding the specific knee replacement device implanted in you. Many knee replacement device manufacturers such as DePuy, Smith & Nephew, Zimmer and most recently B. Braun (Aesculap Replacement Knees) have sold knee systems with design, manufacturing or marketing defects. You can check for recalls and alerts on the FDA website or on other sites such as ICIJ, which collects global implanted medical device data.
The symptoms of a failed knee replacement include severe pain in the knee areas, inflammation, bruising, popping, clicking or crunching noises, inability to flex the knee and loss of mobility.
If your doctor determines that your knee replacement is defective and is harming you, he or she will recommend revision surgery. This is the only way to alleviate the pain and mitigate permanent harm.
What about legal recourse?
Products liability attorneys specialize in obtaining compensation for people that have been harmed by a defective product or medical device. Over the years, there have been thousands of individual and mass tort lawsuits filed against manufacturers, distributors and marketers of products that hurt people.
As of this writing, there are active lawsuits against DePuy Synthes for their Knee Replacement System and B. Braun for their Aesculap Replacement Knees. While none of these suits have yet settled, victims of past defective medical device lawsuits have received compensation ranging from $100,000 to multiple millions of dollars, depending on the circumstances and case types.
Knee replacement surgery can be a godsend for people suffering from severe osteoarthritis and other causes of knee joint damage. Most replacements surgeries are quite successful with patients achieving huge improvements in their mobility and resumption of pain-free physical activity.
Patients that have undergone knee replacement surgery and are in pain or experiencing discomfort, swelling and a decreased ability to walk or stand after the expected recovery period should get checked immediately. A defective knee replacement device may be the culprit and can cause permanent injury and illness if not removed.
If you believe you are the victim of a defective knee replacement, you may be entitled to compensation from the manufacturer. A qualified products liability lawyer can help you determine if you have a case.
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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.LEARN MORE