DePuy’s ATTUNE Total Knee Arthroplasty system (TKA) has been linked to a high risk of premature failure, causing some patients to undergo revision surgery in less than two years.
The FDA approved the ATTUNE TKA system in December 2010 under their 510(k) clearance program. DePuy, a subsidiary of Johnson & Johnson, has sold approximately 400,000 ATTUNE knee implants since it was first released to the public in March 2013.
Orthopedic surgeons and patients alike have complained of the unusually high premature failure rate of the implant. As of June 2017, there have been 1,400 reports of device failure in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Six hundred thirty-three of these reports cited revision surgery.
Patients who required revision surgery after receiving the ATTUNE knee replacement are now filing lawsuits against DePuy.
WHAT ARE THE SIGNS OF ATTUNE KNEE FAILURE?
More than 90% of TKA procedures last 12 years after surgery. The ATTUNE TKA system has failed in less than two years.
Artificial knees last 15 to 20 years for most patients, but the ATTUNE knee replacement has failed in as little as one to two years.
The glue that holds the Attune knee replacement in place may not adequately stick to the tibial component. This loosens the tibial component at the implant-cement interface, causing the entire knee replacement to destabilize.
In a Journal of Knee Surgery article, nine orthopedic surgeons reviewed three hospital databases for Attune TKA system failures. They reported a high-rate of premature failure. Patients experienced pain, effusion, and decreased range of motion within two years after receiving the implant.
Surgeons noted how unusual ATTUNE’s failure rate was: “Total knee arthroplasty (TKA) is believed to be one of the most successful surgical procedures with survivorship of more than 90% at 12 years after surgery.”
Patients who notice the following symptoms may be suffering from premature knee replacement failure:
- Decreased range of motion
In incidents of premature implant failure, patients often must undergo revision surgery, which is typically more invasive and painful than the initial surgery.
DEPUY’S HISTORY OF FAULTY IMPLANTS
In 2013, Johnson & Johnson announced they would settle 8,000 ASR hip lawsuits for $2.5 billion.
Johnson & Johnson subsidiary DePuy Orthopaedics has a long history of manufacturing defective implants.
On December 29, 2016, the DePuy Synthes Radial Head Prosthesis System, an elbow implant, was recalled. The radial stems at the stem bone interface could loosen, causing pain and soft tissue damage, and often requiring revision surgery. Patients who received the implant at any point since December 2013 and required or will require revision surgery are filing lawsuits against DePuy.
Earlier, DePuy was hit with 10,000 lawsuits for their ASR hip replacements. Their ASR Hip Resurfacing System and the ASR XL Acetabular System were recalled due to serious complications, like metal poisoning. In 2013, Johnson & Johnson announced they would settle 8,000 ASR lawsuits for $2.5 billion.
LAWSUITS FILED OVER DEFECTIVE ATTUNE KNEES
“We expect to see increasing lawsuits given the seriousness of the injuries and under-reporting of these injuries associated with the DePuy Attune Knee.”
Multiple lawsuits have been filed against DePuy Orthopaedics for the premature failure of their ATTUNE knee replacement.
The first lawsuit was filed in Circuit Court of Tuscaloosa County, Alabama on September 13, 2017.
The lawyers representing the plaintiff said, “We expect to see increasing lawsuits given the seriousness of the injuries and under-reporting of these injuries associated with the DePuy Attune Knee.” That is precisely what has happened.
Soon after, Joyce Rogers files a lawsuit in the Southern District of Mississippi.
Shortly after Ms. Rogers was implanted with the ATTUNE device in her left knee in February 2015, she suffered from persistent pain, discomfort and instability. Allegedly, this was caused by a lack of bond to the tibial component, and the failure of the overall implant. In November of the following year, she underwent revision surgery to replace the ATTUNE device with a new artificial knee.
WHAT DO ATTUNE LAWSUITS ALLEGE?
Lawsuits allege DePuy was negligent in their design and marketing of the ATTUNE device. Specifically, lawsuits allege that DePuy was guilty of:
- Manufacturing a defective product with a design that had a high risk of loosening and failure.
- Failure to warn of the serious risk of loosening of the tibial component and failure of the ATTUNE device.
- Fraudulently misrepresenting that ATTUNE had been tested and was found to be safe when DePuy knew or should have known of the high risk of component loosening and failure.
ATTUNE LAWSUIT ELIGIBILITY
If you received the ATTUNE TKA system in 2013 or later and required revision surgery as a result of the tibial component part loosening, you may be eligible to file a lawsuit against DePuy.
WHY FILE A LAWSUIT?
Knee replacement revision surgery is often more invasive and painful than the original surgery. In addition to pain and discomfort, patients are often straddled with additional medical costs.
A lawsuit may help recover compensation for the following:
- Medical bills
- Loss of wages (past and future)
- Pain and suffering
CONTACT OUR MEDICAL DEVICE ATTORNEYS
If you required revision surgery after receiving the ATTUNE total knee replacement, you may be eligible for a lawsuit. Our attorneys have extensive experience litigating against manufacturers of faulty medical devices, including defective implants.
Contact us today for a free, no-obligation legal review. It never costs a thing unless we win a verdict or settlement for you.