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. 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 recent knee surgical articles, 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.”
HEALTH RISKS WHEN KNEE REPLACEMENTS FAIL
Patients who notice the following symptoms may be suffering from premature knee replacement failure:
- Pain
- Instability
- Swelling
- Stiffness
- Decreased range of motion
HISTORY OF FAULTY IMPLANTS
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 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.
If you required revision knee surgery after receiving the DePuy Attune Knee Replacement, you may be eligible for a lawsuit against them. Contact us today for a free consultation.
Chhabra & Gibbs, P.A.
Aggressive Workers' Comp & Personal Injury Attorneys