DePuy Knee Replacement Lawsuit
The knee is one of the most important joints in the body, allowing people to walk around freely and enjoy life. However, injury or arthritis can cause crippling pain that leaves a person incapacitated.
When the pain becomes too severe, sometimes a total knee replacement is the only option. Since the first knee replacement was performed in 1968, advancements have been made to implant designs and surgical techniques. Unfortunately, unexpected complications are not out of the ordinary.
That’s what happened in thousands of patients who underwent a total knee replacement with DePuy Synthes Attune Knee Replacement System. Reports of loosening and high failure rates in patients around the United States have prompted a closer look at the implants.
Patients are beginning to blame DePuy for making a defective product by filing lawsuits in court.
Reasons for Knee Replacement Surgery
The Agency for Healthcare Research and Quality reports that more than 600,000 knee replacements are performed every year in the United States alone. Knee replacement, also known as knee arthroplasty, is a procedure done after non-surgical treatments no longer manage the pain.
According to the American Academy of Orthopaedic Surgeons, these are the most common causes of knee pain that require knee replacements:
- Osteoarthritis: As people get older, cartilage in the knee wears away. This results in bones painfully rubbing against one another.
- Rheumatoid arthritis: This is a disease in which inflammation damages cartilage in joints. Eventually, the inflammation can lead to cartilage loss.
- Post-traumatic arthritis: After knee surgery, damage can occur around the joint and worsen over time.
During knee replacement surgery, cartilage is removed before metal components are added to the surface of the joint. The kneecap is also typically resurfaced with a plastic material. A spacer is then inserted between the metal components to provide an easier surface for the material to glide.
DePuy Attune Knee System History
In December 2010, the DePuy Attune Knee System was approved by the U.S. Food and Drug Administration under the agency’s 510(k) approval process.
This is a special expedited approval process in which a manufacturer must prove that the device is “substantially equivalent” to a product already on the market legally. According to the FDA, “a claim of substantial equivalence does not mean the new and predicate devices must be identical.” A device must only be equivalent in design, use, and others.
Devices approved under 510(k) do not need to conduct clinical trials or provide evidence of safety before approval.
In the application, DePuy Orthopaedics said the DePuy Attune Knee System was substantially equivalent to eight other products on the market at the time, such as the Sigma Patella and Zimmer NexGen CR Knee System.
The knee replacement system was originally designed to address the unmet needs of patients around the world. On the DePuy Synthes website, the tagline for the system is “A knee that can help patients get back sooner.”
Components of DePuy Attune System
The DePuy Attune System isn’t just a single device. Instead, it is made up of several components. Here are five major elements, according to DePuy Synthes:
- Attune Gradius Curve: This component is made to work with the femur and tibia. It helps minimize unnatural sliding.
- Glideright Articulation: This aspect deals with the interaction between the kneecap and the femur.
- Sofcam Contact: The Sofcam component helps stabilize the knee when walking.
- Logiclock Tibial Base: This component is attached to the tibia and is essential for stability. It comes in different sizes and offerings to match the femoral size.
- AOX Polyethylene Insert: The spacer is made from a proprietary material marketed as offering excellent wear resistance and long-term stability.
Reports of DePuy Attune Loosening and Failure
Not long after the DePuy Attune Knee System was approved, the FDA began receiving reports of failure in the devices.
This culminated in a widely publicized study published in the Journal of Knee Surgery in September 2017. Researchers examined FDA reports in the Manufacturer and User Facility Device Experience (MAUDE) database related to Attune devices. Hundreds of reports involving the Attune system were found.
After looking through the evidence, the researchers said they had “encountered a high rate of debonding of tibial implant–cement interface.”
In an examination of three hospital databases, researchers found 15 cases of tibial loosening in the Attune system. They also found 21 reports of tibial loosening in the MAUDE database in just the two months before the study concluded.
A response to the study was also published in the journal by Michael A. Mont of the
Department of Orthopaedics at the Cleveland Clinic. Mont warned that the scope of the issue was not yet known and further investigation into the matter was warranted.
DePuy Knee Replacement Recall
So far, there has not been a recall of the Attune system, despite reports of high rates of failure. In 2015, a component of the system was recalled after DePuy found that a wire spring coil in the Attune Knee Tibial Articulation Surface Instruments was prone to damage.
The Class II Device Recall dealt with more than 3,000 units.
DePuy Knee Replacement Lawsuit Filed
Shortly after the release of the study citing loosening in the Attune system, a firm filed the first lawsuit against DePuy Synthes over claims that the device prematurely failed.
The lawsuit was filed in September 2017 in the Circuit Court of Tuscaloosa County by Cunningham Bounds LLC. The lawsuit alleges that Johnson & Johnson and its subsidiary DePuy Synthes created a defective device.
The firm cited the study in the Journal of Knee Surgery as evidence of the high failure rates.
“In most cases, the only medical solution for patients who experience a premature failure of their Attune Knee System is to undergo a revision surgery to remove the implant and replace it,” the firm wrote in a press release. “These revision surgeries are often more painful and invasive than the initial replacement surgery.”
Thousands of patients have already been implanted with the Attune device. Some have had to undergo complicated revision surgery to correct the premature failure of the device.
More lawsuits are expected to be filed against DePuy and Johnson & Johnson related to the Attune Knee Replacement System. Anyone affected by the system is encouraged to contact a qualified attorney to find out more about next steps.