The DePuy Attune knee implant was touted as one of the largest-ever medical device research & development projects. Since its release almost a decade ago, it has been used in more than 400,000 knee replacement procedures.
Unfortunately, reports now show a questionable base plate design of these implants may be causing a high number of early failures when implant components become detached from patients’ lower leg bones.
The problem was first identified when a nationwide group of orthopedic surgeons noticed a high number of patients suffering Attune knee de-bonding in just a period of a few months. A review of area hospitals then found 15 episodes of attune knee failure in the same short period, as well as 21 DePuy replacement cases reported to the FDA medical device database. These studies were published in the June 2017 Journal of Knee Surgery.
Some reports now estimate at least 1,400 patients have experienced early failure of their Attune knee, with almost half needing to undergo a completely new surgery to repair the damage.
During a knee replacement procedure, doctors cut away and reshape parts of the leg bones below and above the knee joint, then use a special adhesive to glue in the new joint device . This can require several days in the hospital and months of recovery. However, typical knee replacements are meant to last for up to 20 years.
Over an unprecedented six-year design process, DePuy engineered the Attune knee to perform even better, with features such as:
Unfortunately, engineers made two key design changes in the Attune that may lead to early detachment. First, the use of a certain polyethylene plastic in place of the natural knee cartilage can cause more stress on the device itself and areas of bone attachment.
Second, the tibial base plate bone attachment components themselves were made much smoother than normal, which can cut down on the ability of adhesives to bond with it. In fact, reports suggest the bonding components of the Attune replacement implant are 75% smoother than earlier models.
The tibial base plate design of the Attune knee system can lead to failure of the adhesive holding the implant to the tibia bone. When this occurs, patients may experience a range of symptoms including:
In most cases of DePuy knee tibial loosening, the problems surface within the first few years after implantation. Unfortunately, even if these symptoms are present, your doctor may not be able to confirm the implant has detached without a second surgery.
In the 2017 Journal of Knee Surgery study that first brought attention to these issues, doctors noticed Attune knee implant loosening in 15 different patients. However, they were only able to diagnose the problem with x-ray in 2 cases. The other 13 cases required surgery to discover the tibial loosening.
Many patients also report difficulty getting their doctor to take their complaints seriously when the detachment can’t be seen on x-rays. Therefore, your case may require a second opinion review by another doctor or a thorough medical records review by a lawyer.
DePuy Orthopedics is the second largest manufacturer of knee replacement implants in the world. And, over the past 15 years, they’ve had their share of product recalls.
In fact, from 2003 to 2013, DePuy had the most knee system and component recalls of any knee implant maker, with almost 280. The company has also recorded the most Class I recalls, which are reserved for those products reasonably likely to cause serious injury or death.
Some of the most recent knee implant products recalled by DePuy include:
Despite these earlier actions, there has not yet been a DePuy Attune knee recall. Experts believe the company may attempt to remedy the tibial bonding issues without the publicity of a recall, through physician training or substitution of certain components.
However, this doesn’t address the thousands of patients that have already been injured by Attune de-bonding or those that will need revision surgery in the coming years.
In the meantime, anyone who has experienced the symptoms of Attune implant loosening or has undergone revision surgery should speak with a lawyer about their rights to seek compensation through a lawsuit.