The DePuy Attune Knee replacement system has been found to cause premature failure when the cement component comes unglued from the device.
DePuy Attune knee replacement system is one of many medical device units manufactured by pharmaceutical giant, Johnson & Johnson. Many recipients of the device have experienced complications, leading to severe pain and replacement surgeries.
One of the problems causing device failure is a small component; a wire spring called the “balseal” has been found to detach and can embed into the tissue surrounding the artificial knee. Among other things, this can lead to catastrophic falling incidents.
In 2015, the U.S. Food and Drug Administration issued a recall of the Depuy Attune Knee Replacement System, citing the balseal as the main reason for the device design failure.
The report stated: “Potential for the Balseal, a small wire spring coil located on the post feature of the Attune Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.”
Another process that causes the device failure is known as “debonding”, in which the glue that holds the device in place comes undone. When this happens, the lower part of the leg is free to move in a way that can cause horrendous pain and can lead to falling.
In a report issued by the Journal of Knee Surgery, nine orthopedic surgeons reported premature device failure in the Attune Knee System. The surgeons specifically stated the debonding failure of the tibial implant-cement feature to be the culprit.
Side Effects of Device Failure
The common symptoms of device failure from the Attune knee replacement system include:
- Instability and loosening
- Unusual swelling around the site
- Decreased range of motion
- Persistent pain
- Nerve pain
- Wobbling or a feeling of looseness
- Abnormal warmth in the surgery site
According to the FDA MAUDE database, the knee replacement failure typically occurs within two years of the initial surgery. The company guarantees the device lasts between 15 and 20 years.
Revision Knee Surgery Complicates Quality of Life
People opt for knee replacement surgery for a variety of reasons. Many people in the United States undergo knee replacement to treat symptoms of osteoarthritis. Another reason knee surgery is required is due to being overweight.
The knee is one of the most overworked joints in the body due to the amount of pressure it can withstand. If a patient is overweight, the strain it puts on the knee can cause premature failure.
Knee surgery is no joke. It involves extensive physical rehabilitation in the recovery time after surgery, usually anywhere from six months to a year. In addition, it requires that the patient maintain a healthy fitness routine for the remainder of their lives.
Unfortunately for patients who experience device failure from Depuy Attune, the only option to fix it is to undergo revision surgery. This removes and replaces the implant with a new one. Revision surgeries are significantly more painful than replacement surgeries.
Furthermore, when a device fails it causes not only physical pain, but can affect a person’s quality of life as well. The time it takes to recover after the first surgery can cause financial stress, especially if the patient has to take time off from work. Coupled with a revision surgery, this can have a devastating impact on the patient and their family.
If you or someone you know has potentially experienced device failure with the Attune knee replacement system, it is imperative to stay off your feet and contact your healthcare provider immediately. Standing can complicate matters by causing the device to wear on the tibia and initiating bone loss.
Do I Have a DePuy Attune Knee Replacement Lawsuit?
If you or a loved one has suffered complications after a knee surgery procedure where the DePuy Attune system was used, you may be entitled to financial compensation for your injuries by filing a lawsuit. To learn how we can help you and your family, please contact us for a Free Case Evaluation. We would be honored to speak with you and will respond promptly to every inquiry we receive.