Attune® Knee System Recall and Lawsuits
Knee replacement surgery is extremely common here in the United States, with nearly a half million procedures conducted annually.
This procedure is intended to increase the patient’s quality of life, not detract from it.
If you have had a knee replacement surgery with the Attune® Knee Replacement System and are experiencing adverse side effects, you could be eligible for a settlement.
DePuy Synthes, a subsidiary of Johnson & Johnson, introduced The Attune® Knee System in March of 2013. It is implanted during a total knee replacement surgery or knee arthroplasty surgery and replaces the entire knee joint with artificial components. These components are mechanically connected to the femur bone (at the top) and the tibia bone (at the bottom). Ideally, such a surgery will improve joint function and reduce pain.
Unfortunately, the Attune® component intended to attach to the tibia (the tibial baseplate or tibial tray) can come loose, or “debond,” and cause loss of function and pain. Such loosening can also cause bone loss and often requires a revision surgery to replace the defective component and reconstruct the bone loss. A simple x-ray may be able to determine if the baseplate has come loose.
DePuy’s History of Lawsuits & Recalls
The first DePuy Knee Replacement Lawsuit was filed in 2017 against DePuy and Johnson & Johnson. (4)
This is not the first failed medical device DePuy has faced in court.
In May 2013, DePuy announced that it was taking all of its metal hip implants off the market. Earlier, in August 2010, J&J and DePuy recalled other DePuy metal hip implants, the ASR XL Acetabular and ASR Hip Resurfacing system, and a settlement program was created for patients with faulty ASR hip implants.
The FDA and ATTUNE®
Class 2 Device Recall ATTUNE" Articulation Surface issued in 2015. MEDICAL DEVICE CORRECTION was issued for all lots of the affected devices. The device correction is to inform US Distributors and Medical Professionals about the issue, how to prevent the issue, and any actions to take. (6)
June 2015 – (voluntary) Attune recall
Components not approved by FDA, and other components altered to the point where they are no longer safe. Some medical device components fly under the radar of the mandatory FDA approval process if they replicate a device that has already been approved in the market.
As of 2015, the FDA issued a Class I recall against DePuy Synthes.
Persons Affected by ATTUNE®
Of the 400,000 of these systems have been used during total knee replacement procedures, 3475 units of the Attune knee replacement device have been affected between 2012-2017.
Serious Reported ATTUNE® Side Effects Include:
- Abnormal warmth
- Unexplainable swelling and severe pain
- Significant pain
- Bone loss
- Muscle damage
- Reduced mobility
- Scar tissue forming around the dislodged component may cause scarring, nerve damage and decreased range of motion, as well as clicking sounds or grinding
- Infections from metal and plastic shavings caused by the Baleal remaining around the artificial knee can also result
- Tibial fractures due to misalignment of the lower and upper leg
FREE ATTUNE® Lawsuit Consultation
Talk to your doctor if you are experiencing any of these side effects after your knee replacement surgery. A simple x-ray may be able to determine if your implant is malfunctioning. Revision surgery may be required to repair or completely replace the artificial knee.
If you or a loved one has suffered due to a defective Attune® Knee System, the experienced attorneys at Reyes Browne Reilley can help you pursue just compensation for your medical expenses, lost wages, and the pain and suffering you have endured.