It is believed the failure occurs because the part of the knee that attaches to the tibia is too smooth and the glue has difficulty holding the ATTUNE® Knee to the tibia bone.
Because the glue does not properly adhere to the ATTUNE® Knee, the prosthesis can become loose from the tibia bone, resulting in pain and in many cases, a premature revision surgery. This failure can occur within months or a couple of years after the original surgery. Typically, the surgeon in the revision surgery will find that the glue is not adhered to the tibia plate.
Lawsuits have been filed against the manufacturers of this defective system. If successful, plaintiffs can be compensated for a variety of damages, including the costs of revision surgery, pain and suffering, and loss of enjoyment of life. If you or a loved one received an ATTUNE® Knee System and have suffered adverse effects, you may have a case. Contact an experienced defective medical device attorney at Carey Danis & Lowe to learn more.
DePuy ATTUNE® Knee Systems Have a Higher Failure Rate Than Other Similar Knees
In a study published in the Journal of Knee Surgery, doctors from across the U.S. have reported an unusually high rate of knee replacement failure in months or years after the replacement.
More specifically, the failure is occurring because the device was designed with an abnormally smooth surface resulting in the medical glue not properly bonding the implant to the patient’s tibia bone. This can cause a range of complications, such as loosening and dislocation of the device, in addition to metal debris.
The DePuy ATTUNE® Knee System did not go through typical clinical trials prior to FDA clearance pursuant to the FDA’s 510(k) fast-track process.
When a company puts a medical device on the market, they can go through the entire pre-market approval process, which requires the device to go through clinical trials and prove that the device is safe and effective prior to being allowed on the market. The FDA also has a process called the 510(k) process, which allows a company such as DePuy to put a device on the market even though it has not gone through clinical trials by showing that it is similar to another device already on the market.
The DePuy ATTUNE® Knee went through the 510(k) process and was cleared without clinical trials showing that it was safe and effective.
Since the DePuy ATTUNE® Knee has been on the market, there have been a significant number of reports to the FDA of failures of the knee due to loosening of the tibial component. The failure rate is much higher than other knees, and it is reported that the failure rate is 10 times as much as similar knees. As a result, the law firm of Carey Danis & Lowe has sued DePuy regarding the ATTUNE® Knee System.
There have been reports of failures and adverse events regarding the DePuy ATTUNE® Knee. It is estimated roughly 1,500 such reports have been made to the FDA. It is generally accepted that adverse event reports are under-reported, and that typically for every adverse report filed with the FDA, there are 10 to 100 unreported.
The Risks of a Revision Surgery
In addition to enduring a revision surgery process, which has the same risks and side effects as the original implantation surgery, there are additional risks in patients undergoing a revision surgery. When you have a second operation in the same location, you face an increased risk of morbidity due to infection, a risk that the revision surgery will not be effective due to additional scar tissue, and other problems associated with the revision surgery.
Do You Have a Case Against DePuy for the ATTUNE® Knee System?
If you were implanted with the DePuy ATTUNE® Knee System and then within a few months to several years after the surgery had a loosening of the tibial component, you most likely have a cause of action against DePuy for damages as a result of having a premature revision surgery.
In addition, when you have a revision surgery you have additional risks as with any surgery, which could be infection, limited range of motion, and difficult and painful physical therapy. You also will have to take additional time off work and incur the costs of an additional operation.
If you believe that you have a case against DePuy for the ATTUNE® Knee, please contact Carey Danis & Lowe, and we will immediately obtain your medical records, evaluate your case, and file the case if we believe you have the particular defect we are investigating.