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The Attune Knee lawsuit claimed the medical device was defectively designed so that its surgical glue would not properly hold the device to a patient’s tibia bone. This caused early failure, immense pain, and loss of mobility.
Attune Knee Systems failed at a higher rate than expected. The failure occurred because the medical device was designed with too smooth a surface so that medical glue had difficulty holding the Attune Knee to a patient’s tibia bone. Testing showed the Attune Knee was 75% smoother than previously designed knee replacement prosthetics.
Because the glue-like substance (similar to cement) could not adhere to the Attune Knee replacement, the medical device would come loose from the patient’s tibia bone, which resulted in extreme pain and limited mobility. This failure often was occurring within two years after surgery, even though the device should last at least 12 years, and often up to 20 years.
A total knee replacement is considered a major surgical procedure. The knee is the largest and hardest-working joint in the body. The orthopedic surgeon removes the damaged knee joint and replaces it with a prosthetic joint, usually made from metal, ceramic, or plastic. The ends of the femur (thigh bone) and tibia (lower leg) must be removed and cut to shape in order to receive implants that mimic the natural shape of the joint.
In order to adhere the knee replacement to the patient’s natural bone, a special type of adhesive cement is employed. The failure of this adhesion process is the primary issue behind the alarming failure rate of the DePuy Attune system.
Below are the signs a patient should look for in order to determine whether the Attune Knee replacement is failing.
In June 2017, a study was published in the Journal of Knee Surgery in which the researchers found that the cement-to-implant interface involving Attune Knee implants had come loose. Of the fifteen failures discovered, however, only two had been seen on x-ray images. This means that doctors could not have known of thirteen of the failures without first removing the device based on the patient’s symptoms and complaints.
There are a number of reasons why the researchers found the glue was not holding. One of these is the limitations of the polyethylene plastic component in the Attune Knee, which is causing greater load-bearing stress on the interfaces. Another reason is the “roughness factor” of the components in the medical device. A relatively rough texture is necessary in order to hold the adhesive in place. 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.
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. The new joint should then be good for a minimum of 12 years, and up to 85% of the devices can last for 20 years or more.
Knee arthroplasty, or replacement, is the most commonly-performed bone operation in the United States, with over 600,000 procedures being performed annually. In most cases, knee arthroplasty is indicated for age-related conditions such as arthritis, which weaken and/or destroy the cartilage surrounding the knee.
Most candidates for knee arthroplasty are age 45 or older. However, it is also indicated for patients who have suffered injuries, such as a broken bone or torn ligament, or have knee deformities (“knock knees” or bowed legs).
Knee replacement surgeries have been carried out successfully since 1968. For the majority of patients, a total knee replacement should last twenty years. According to the American Association of Hip and Knee Surgeons, knee replacements have an annual failure rate of less than 1%. Most of these are caused by other complications, such as infection. Rarely is it caused by the device itself.
In an article published in the Journal of Knee Surgery, nine prominent orthopedic surgeons reported that they have encountered an unusually high-rate of premature failures of the Attune Knee System. The surgeons attributed the failures to the debonding of the tibial implant-cement interface. Reported in Orthopedic Design and Technology
“Patients presented with pain on weight bearing, effusion and decreased range of motion (ROM) within 2 years after surgery. Radiographic evaluation demonstrated loosening of the tibial components in 2 of 15 knees. This included cruciate retaining, posterior stabilized, fixed bearing and rotating platform bearing designs,” study authors wrote. “Intraoperative findings demonstrated gross loosening of the tibial component at the implant-cement interface.” Reported in Mass Device
A novel design total knee arthroplasty (TKA) system has been introduced to improve patient outcomes and increase longevity. However, we have encountered a high rate of debonding of tibial implant–cement interface. In addition, multiple reports have been filed in Manufacturer and User Facility Device Experience database with the same mechanism of failure. Reported in The Journal of Knee Surgery – Attune Knee Failures
We propose that the early failures seen in this case series may be associated with the use of HVC cement. In the setting of a negative infectious workup and no radiographic evidence to suggest loosening, the surgeon should consider debonding of the tibial component as a potential cause for persistent pain if HVC cement was used with this prosthetic design. Reported in Journal of Arthroplasty
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