DePuy Attune and Sigma knee replacement products were designed to last longer and provide better stability for younger, more active patients. While most surgeries have been successful, many people who received DePuy Attune or Sigma knee replacement devices have experienced serious complications after their implant failed to perform as expected.
In addition, the U.S. Food and Drug Administration has received a high number of adverse event reports filed over complaints and complications caused by the devices.
Many of these recipients have filed DePuy Knee Replacement Lawsuits to seek compensation for their injuries including:
- Early device failure
- Severe pain
- Joint instability
- Bone loss and Fracture
- Nerve and tissue damage
- Joint revision surgery
The first DePuy knee replacement lawsuit was filed in 2017 for injuries caused by the DePuy Attune knee device. Additional cases have followed, including a number of DePuy Sigma knee lawsuits. DePuy and parent company, Johnson & Johnson are expected to face hundreds or even thousands of knee replacement lawsuits over the Sigma and Attune knee devices.
DePuy Attune Knee Replacement
The DePuy Attune knee system is a total knee replacement system which includes components to replace both the upper and lower portions of the knee joint. It was designed to improve natural movement and result in quicker recovery and intended for younger, more active patients. DePuy Attune is constructed from a Cobalt-Chromium alloy, and a proprietary polyethylene plastic.
The DePuy Attune system was first cleared by the Food and Drug Administration (FDA) in 2010 under the FDA’s 510(k) approval process, which allows companies to avoid conducting clinical trials if their products are “substantially equivalent” to devices previously cleared by the agency. Because of this process, the Attune device was not tested in humans before introduction to the market.
DePuy introduced two modifications to the device in 2014 and more new features in 2016. The addition of a rotating platform design and an artificial patella were intended to reduce implant wear and improve range of motion, while maintaining stability.
Problems with the Attune Knee Device include:
- Loosening of the device due to cement failure
- Bone fractures
- Unexpected wear and tear
- Early device failure
- Revision surgery
Some of these complaints are documented in a 2017 study published in the Journal of Knee Surgery and have been echoed in medical device adverse event reporting to the FDA. Though devices are usually intended to last for about 15 years, multiple patients reported pain on weight bearing, decreased range of motion and other problems within the first two years after receiving the devices.
The FDA’s MAUDE database which tabulates adverse events shows that over 1,400 reports of Attune device failure had been received by 2017, over 600 of which required revision surgery. The first DePuy Attune Knee Replacement Lawsuit was filed in 2017 and many additional lawsuits have followed. DePuy also faces a number of lawsuits filed in Canada.
DePuy Sigma Knee Replacement
DePuy Sigma Total Knee system is an older system that was approved in 1996 and marketed as a comprehensive, integrated knee system. It was designed based a prior version, the PFC system with the goal of giving surgeons the flexibility to personalize the implantation depending on the individual patient needs.
The Sigma knee system employs fixed bearing technology or rotating platform technology and utilizes a highly-polished cobalt-chromium construction with rounded geometry, along with proprietary antioxidant polyethylene components which are intended to reduce wear and prevent oxidation.
A system named “TRUMATCH” Personalized Solutions is offered to improve preoperative planning for better patient matching which is intended to reduce complexity and reduce surgical time.
Problems with the Sigma knee system have included:
- Joint instability
- Severe pain
- Early wear and tear
- Bone loss
- Revision surgery
Some of these complications have been included in several studies and journal articles including publication in Clinics in Orthopedic Surgery and the Journal of Arthroplasty. The first DePuy Sigma Knee Replacement Lawsuit was filed in 2018.
DePuy Sigma and Attune Knee Recalls
Though no whole-device recall has been issued for the DePuy Attune Knee replacement system or components, the company has been required to issue voluntary recalls for instruments associated with the DePuy Attune knee system and for certain portions of the Sigma line.
In 2009, A class 2 recall was issued for a component of the DePuy Sigma Knee System after a risk of crack formation was discovered. In 2012, a voluntary recall was issued for Sigma devices after the FDA warned DePuy that it had failed to seek approval for commercial sale of certain devices. Once the concerns were addressed, the devices returned to market.
In 2015, an Attune recall was issued over concerns that a surgical tool included in the device installation package could break off and leave fragments inside the patient. The potential problem was identified as a spring in one of the surgical instruments which was prone to damage.
In 2017, DePuy was forced to recall part of the Sigma device line. The Sigma HP PFJ cemented trochlear implant which is attached to the femur to provide the patellar groove needed for knee movement was found to be prone to loosening and becoming dislodged or misaligned.
DePuy has also faced recalls and warnings for other surgical and joint replacement devices including surgical tools and hip replacements.
DePuy Knee Replacement Complications
Over 700,000 knee replacement surgeries are performed each year in the U.S., many of them using DePuy devices. The Sigma knee system has been implanted in an estimated 1.7 million patients since its approval and the Attune system, though newer, has been just as popular.
Though most surgeries are successful, patients who experience device failure can be subjected to debilitating side effects and complications.
Severe side effects of the DePuy Sigma and Attune knee implants have included:
- Inflammation, bruising or swelling
- Severe pain
- Infection
- Blood clots
- Nerve and blood vessel damage
- Knee dislocation
- Bone fractures
- Bone dissolution or bone death
Severe side effects and complications may cause severe pain, loss of function and result in disability. In order to address complications, a joint revision surgery may be required to remove and replace a faulty device with a new, functioning artificial joint. In some cases, joint reconstruction may be needed and may require more than one repeated surgery.
DePuy Sigma and Attune Knee Replacement Claims
Lawsuits filed by people who were injured, experienced complications, or required revision surgery after a DePuy Attune or Sigma knee device was implanted have claimed that Johnson & Johnson and its device subsidiary, DePuy:
- Designed and produced defective devices
- Failed to warn the public about risks of complications
- Failed to issue recalls appropriately
- Marketed products as safe and effective despite risks
DePuy and parent company Johnson & Johnson are facing numerous lawsuits for both the Attune and Sigma knee devices.
People who were injured or required revision surgery after receiving a DePuy Attune or Sigma knee implant may be eligible for compensation for their injuries.