This Spring, Johnson & Johnson subsidiary DePuy Synthes Orthopedics announced the launch of the new Attune Revision Knee System, a secondary replacement designed for those patients who’ve experienced failure of their primary knee implant.
In doing so, the company hailed the new revision system as a way for doctors to offer a comprehensive system that would complement the initial Attune knee implants once they reach the end of their useful life.
However, with increasing reports of patients experiencing early failure of their primary Attune knee implants due to tibial loosening and de-bonding, the move may also be an attempt by DePuy to profit from their mistakes and the resulting misfortune of their customers.
What are Revision Knee Implants?
Around 750,000 people annually undergo knee replacement procedures due to pain, lost mobility or damage to their natural knee. These are known as primary knee replacements and, in most cases, can improve mobility and function for up to 15 to 25 years.
However, in about 1 out of 10 cases, these primary knee implants fail early and patients must undergo another surgery to replace the malfunctioning device with a second knee implant. This is known as a revision knee.
Most often, knee implant failure leading to revision surgery is due to infection, excessive wear, pain, excessive scar tissue or the loosening of the primary implant from the leg bones.
Revision knee surgery involves removing the primary implant, repairing bone or soft tissue that has been harmed by infection, inflammation or trauma, prepping the area to receive the revision knee implant, and installing the new device.
Because of the additional steps involved to remove the old implant and repair any existing damage, the revision procedure is much more invasive. It also takes longer to recover and the revision implant is not expected to last as long as a primary implant.
Early Failure & Loosening of DePuy Attune Knees
Critics say part of the reason for the launch of the new Attune Revision Knee from DePuy may be an attempt to profit from early failure of their primary knee implants. This is based on numerous reports that patients’ Attune knees have become unglued due to design flaws.
Although DePuy boasted that the Attune knee was their largest orthopedic R & D product in history, FDA reports show it has failed at almost 10 times the rate of similar implants like the Zimmer Persona.
The problem starts with the base plate of the Attune implant, which is glued to the lower leg bone, or tibia. DePuy made this part nearly twice as smooth as earlier versions, which didn’t give much for bonding agents to adhere to.
As a result, the FDA has already received more than 1,500 reports of Attune knee failure or loosening. This can lead to infection, bone and tissue damage, pain, instability and the need for revision surgery.
Patient Legal Options & DePuy Attune Lawsuits
Despite knowing about the bonding problems of the Attune knee for years, DePuy defended their product and never issued a recall.
Privately, the company acknowledged an issue with the implants to the FDA in 2016 and launched an improved version of the Attune knee with better bonding capabilities in 2017.
However, DePuy gave no recall or warning to doctors or the more than 600,000 patients who received the defective first version of the Attune knee.
Now, hundreds of patients with failed Attune implants requiring revision surgery have filed lawsuits against the company for selling a defective product while failing to warn of the health risks.
So far, lawsuits have been filed in numerous states across the country on behalf of DePuy Attune knee patients. And, due to the number of victims involved and scope of the litigation, lawyers expect cases will be consolidated to a special federal multidistrict court later this year for quicker handling.
Anyone who experienced failure or complications with their Attune knee implant has the right to file a claim. They may be entitled to substantial compensation for their medical costs, lost time, pain and suffering.
However, there is a time limit on how long you have to take action. Those who believe they may have a defective knee implant should speak with an attorney as soon as possible to learn what steps to take to protect their rights. This is true whether or not you’ve undergone revision surgery.
DrugNews works only with lawyers that have handled thousands of defective medical device lawsuits and are actively involved in the current DePuy Attune litigation. For more information or to speak directly with a lawyer at no cost, contact us today.
DePuy Synthes. New ATTUNE® Revision Knee System from DePuy Synthes Utilizes ProprietaryTechnologies to Address Broad Range of Complex Primary and Revision Procedures. (March 6, 2018). Retrieved from www.prnewswire.com
Bonutti, P. et al. Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant–Cement Interface. The Journal of Knee Surgery. (June 7, 2017). Retrieved from www.thieme-connect.com
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Since news broke last year that medical device maker DePuy Orthopedics had ordered a secret DePuy Attune knee recall, the company has been trying to combat a series of negative reports and hundreds of consumer lawsuits by those needing revision surgery.