Attune Knee Implant Injuries
Many Americans suffer severe joint pain. Joints damaged by trauma, arthritis, repetitive stress or disease, can greatly impact daily life. Damaged joints can leave many patients unable to enjoy normal activities with their family and friends. For some people, the pain and limitations can be disabling.
As medical technology and surgical techniques develop, many patients now have options for joint replacement. Knee and hip replacement have become common surgical procedures. Over 600,000 Americans receive surgical knee replacements each year. Knee replacement surgery (called arthroplasty) is a common procedure. Orthopedic surgeons across Alabama regularly perform knee replacement. In Huntsville, Birmingham, and several other Alabama cities, patients have excellent choices when considering surgeons.
For many patients, a joint replacement provides an opportunity to regain an active lifestyle. These surgeries can also help many individuals extend their work life. Implant products should last many years. Most patients undergoing knee, hip or shoulder replacement, gain many years of active life and work. However, when the materials or products are defective, patients are left suffering greater pain, increased disability and the added trauma of more surgical procedures.What is the Attune Knee Implant System?
The Attune knee implant system was developed by Depuy Synthes (Depuy). Depuy is a subsidiary of Johnson & Johnson. In 2010, Depuy received FDA clearance to market its initial Attune knee system in the U.S. under the 510(k) process. We have written several articles about the FDA’s 510(k) process. You can read some of them on our law firm blog. We believe the 510(k) process has been flawed and allowed numerous defective medical devices to be marketed. Many patients have been needlessly injured by defective devices marketed pursuant to this regulatory loophole. Transvaginal mesh implants (TVM) are another example of products marketed pursuant to the flawed 510(k) process. Our office has represented numerous Alabama women who suffered permanent personal injuries after a TVM implant. Johnson & Johnson, through another of its subsidiaries, marketed one of these TVM implant devices.What is the Problem with the Attune Knee Implant?
The concern with the Attune knee system is that the fixed bearing tibial baseplate can become loose and detach. The failure is believed to occur due to the design of the device surface. This can lead to a catastrophic failure of the implant. The patient can suffer tremendous personal injury.
A study published by the Journal of Arthroplasty in June 2016 warns that certain knee implants like Attune may have high rates of baseplate loosening due to thicker cobalt-chromium tibial trays. A subsequent study published by the Journal of Knee Surgery in 2017 reports a high-rate of early failures with the Attune system. The surgeons who authored the 2017 article attributed the failures to the debonding of the tibial implant-cement interface. The “glue” used to hold the implant in place does not adequately “stick” or “adhere” to the tibial component of the system. This is due to the specific design of the Attune system. Because of this, the tibial component can loosen and destabilize the knee.
Numerous adverse events have been reported to the FDA involving the Attune system. Many of the reports indicate tibial baseplate detachment. In September 2017, lawyers filed the first Attune replacement personal injury lawsuit.
Surgeons have implanted the Attune knee system in patients across Alabama and the United States. What are some symptoms or signs of knee implant failure? Symptoms may include:
- Loosening of the joint
- Decreased range of motion
- Persistent pain
- Swelling or inflammation
- Warmth or heat in the knee area
Attune knee system failure typically occurs within two years of the implant surgery. Knee replacement failure is a serious personal injury. Revision surgery to repair a failed Attune knee replacement implant is not a simple process. Revision surgery also places the patient at additional risk of infection, chronic pain and disability.
If the manufacturer had provided the appropriate warnings to doctors and their patients about the risk of failure, many would have chosen another knee implant option. Needless personal injury and damage could have been avoided.
The Blackwell Law Firm is reviewing potential injury claims involving patients implanted with the Attune knee system in Alabama. If you have questions or would like to discuss your injury, give us a call. We are happy to provide additional information. Consultations are always free and confidential.