A total knee replacement is considered a major surgical procedure, and one of the most common procedures in the U.S., with about 700,000 knee replacement procedures performed annually. This number is predicted to increase to 3.48 million procedures per year by 2030. The Centers for Disease Control (CDC) reports that knee replacement rate has nearly doubled from 2000 to 2010, and that in 2010, total knee replacement was the most frequently performed inpatient procedure on adults aged 45 and over.
What is a DePuy Attune Knee Replacement System and Who is it Made For?
The Attune Knee System was designed by DePuy Synthes (a subsidiary of pharmaceutical giant Johnson & Johnson) to improve stability and range of motion in knee replacement patients. DePuy marketed this knee to a younger and more active demographic. In fact, the American Academy of Orthopedic Surgeons says that “ Half the patients now receiving knee replacements are younger than 65 years of age, and most of them are in the workforce.”
When younger patients experienced knee pain, the standard practice used to be pain killers or steroid injections for several years to tide them over until surgery. But companies such as DePuy latched onto this younger and more active demographic (with the average age of 61 years old) and marketed their devices accordingly.
During an interview with Ring of Fire co-host Farron Cousins, attorney Daniel Nigh said that, “If you had a knee replacement in the last six or seven years, you probably have somewhere between a 10 percent to 30 percent chance of having the Attune knee replacement device.” LINK to What you can do/ be pro-active pg 6 Lawsuit Funding
According to DePuy, the Attune device produces better stability of the knee in deep flexion, reduces the joint forces, and produces better patella tracking, operative flexibility and efficiency, and implant longevity. DePuy also promoted this “novel design total knee arthroplasty (TKA) system” to improve patient outcomes and increase longevity, which typically lasts a minimum of 15 years. But the Attune knee can actually become worse than the actual knee it replaced, and the device can fail in less than a few years.
Attune Knee Problems – Why it is Failing
Despite DePuy’s claims, the Attune Knee Systems have been failing at a higher rate than expected. This failure is often occurring within two years after surgery, even though the knee devices have an average life span of 15 years. The primary reason the Attune knee fails is mechanical loosening, which is caused by a failure of the bond between the tibial baseplate at the implant-cement interface. Mechanical loosening means that the attachment between the artificial knee and the existing bone has become loose. Such loosening will eventually result in failure of the device. And the Attune Knee has been failing at an alarming rate.
A special type of adhesive cement is needed to adhere the implant to the patient’s natural bone. Recent literature has shown debonding of the tibial implant-cement interface as a potential cause for implant loosening. the Journal of Arthroplasty (Nov 2016) says it may be associated with the use of HVC cement. Other researchers found the “glue” isn’t holding due to limitations of the polyethylene plastic component, which is causing greater load-bearing stress on the interfaces. Another reason is the “roughness factor” of the components in the Attune knee. In order to hold the adhesive in place, a relatively rough texture is necessary. In the case of the Attune Knee System, this “roughness factor” is only 60, whereas similar devices can have a roughness factor of up to 220. Testing shows the Attune Knee is 75% smoother than previously designed knee replacement prosthetics.
Attune Knee Injuries and Side Effects
The Attune knee implant has been linked to reports of pain and premature implant failure, resulting in the need for revision surgery. When the glue fails, the Attune Knee comes loose from the patient’s tibia bone, which results in extreme pain and limited mobility, and possibly a severe infection.
Generally, you won’t notice it loosening for maybe the first year or so. But in time, as you move on that knee more and more, there’s going to be more problems.
When a knee replacement fails prematurely, it can result in a number of serious complications, which can include:
Inflammation and swelling
Loosening of the joint
Loss of mobility
Loss of range of motion
Warmth or heat in the knee
What is Knee Replacement Surgery and Why is it Performed?
The knee is the largest and hardest-working joint in the body, and it wears out with use.
Your doctor may recommend knee joint replacement if:
You are having pain from knee arthritis that keeps you from sleeping or doing normal activities.
Your knee pain has not improved with other treatment.
You cannot walk and take care of yourself.
You understand what surgery and recovery will be like.
Knee joint replacement is a surgery to replace a knee joint with a man-made joint. The orthopedic surgeon removes the damaged knee joint and replaces it with a prosthesis, usually made from metal, ceramic, plastic, or a combination of these materials.
These pieces may be placed in the following places in the knee joint:
Lower end of the thigh bone. This bone is called the femur. The replacement part is usually made of metal.
Upper end of the shin bone, which is the large bone in your lower leg. This bone is called the tibia. The replacement part is usually made from metal and a strong plastic.
Back side of your kneecap. Your kneecap is called the patella. The replacement part is usually made from a strong plastic.
Knee replacement surgery usually requires a hospital stay of 4 to 5 days, and an initial recovery period of six weeks. However, full recovery can take six months to a year.
Knee Revision Surgery
DePuy promised patients that they could recover faster, and engage in more active lifestyles. Instead, the Attune knee is causing patients to experience additional pain and injury, often resulting in revision surgery. Some patients say they were worse with the artificial knee than before it was implanted. DePuy, like other medical device companies, doesn’t offer a warranty to reimburse patients who are implanted with a defective knee replacement system. Instead, patients who need revision surgery are often faced with costly medical bills.
Revision surgery is more complicated than the initial knee replacement and recovery time can take up to 50 percent longer than replacement surgery recovery. The American Academy of Orthopedic Surgeons says that revision surgery is “a longer, more complex procedure that requires extensive planning, and specialized implants and tools to achieve a good result.”
The success rate of a revision surgery is much lower than that of the initial total knee replacement and the risks and complications are higher, including limitations in range of motion, the ability to walk, and even death. And any hospital stay comes with its own set of risks, including infection.
According to court documents, the FDA MAUDE database (June 2017) includes approximately 1,400 reports of failures, of which 633 of these reports resulted in revision surgeries. By comparison, for the Persona knee replacement system, approximately 384, 000 devices have been implanted, and the MAUDE database has a collection of only 183 reports of device failures with 64 of these resulting in revision surgeries.