Attune Knee System
The Attune Knee System was supposed to improve the results of knee replacement procedures, but the results have not been favorable for many recipients.
What is the Attune Knee System?
Johnson and Johnson subsidiary DePuy Synthes is one of the largest manufacturers of artificial orthopaedic implants and components used to partially and totally replace knee joints. One of these implants is the Attune Knee System. However, in recent years, DePuy Synthes has filed a number of reports with the US Food and Drug Administration reporting premature failure of the Attune Knee System which has resulted in the need for revision surgeries.
The Attune Knee System was approved by the FDA as a replacement option for patients with knee arthritis, injury, and excessive wear and tear. Introduced by DePuy Synthes in March 2014, the Attune Knee System includes a number of components, including the Attune Gradius Curve, Attune Rotating Platform Knee, and the Anatomic Patella.
The rotating platform was designed to address feelings of instability when descending down stairs and bending in knee replacement patients. The rotating platform was designed to provide an enhanced range of motion and improved stability and to reduce stress and wear on the implant.
Studies have shown that 10 to 20 percent of knee replacement patients were not completely satisfied with their knee replacement. DePuy Synthes designed the anatomic patella to wrap around the knee more naturally and improve patella tracking.
How does the Attune Knee System work?
Total knee replacement surgery involves resurfacing the bones at the top of the shin and bottom of the thigh with implants made of metal and plastic materials. The shin bone is resurfaced using a plastic spacer (called a bearing), which replaces the cartilage and provides cushioning for the new knee. The bottom of the thigh is resurfaced with a rounded metal part, designed to mimic the curve of the knee. In some replacements, the under surface of the knee will also be replaced.
The bearings used can be either fixed or rotating. The Attune system involves a rotating bearing–which means that the knee can move more naturally as the knee bends, unlike the fixed bearing, therefore improving stress and wear on the implant.
Zimmer Knee Replacement Side Effects
As with any invasive surgery, there are risks of complications from anesthesia and the surgery itself. Specific knee replacement side effects are:
The most common side effects from knee replacement surgery are, swelling, bleeding, stiffness, pain and soreness, blood clots, and nerve and tissue damage. Side effects of anaesthesia include: vomiting, dizziness, shivering, sore throat, aches and pains, and discomfort.
The serious side effects of anesthesia include: dental trauma, swelling of the windpipe, allergic reactions to latex, wheezing, vocal cord injury, stomach problems, and injuries to the arteries, veins, or nerves.
Serious complications of knee replacement surgery are blood clots, nerve and artery damage, heart attack or stroke, infections, allergic reactions, the kneecap moving away from the tibia (shin) after surgery, and bone fractures during surgery.
The most challenging complication is the loosening of the implant due to either a faulty implant or poor positioning. Symptoms associated with premature failures of the Attune Knee System include:
- Instability and Loosening
- Unusual Swelling
- Decreased Range of Motion
- Persistent Pain
- Fractures of the bone around the knee replacement.
Premature failure will require revision surgery which can be painful and has its own complication risks.
- Loosening of the implant
- Poor positioning
- Faulty implant
- Kneecap moving away from the tibia
- Premature failure
- Unusual swelling
- Persistent pain
- Nerve, tissue, and artery damage
- Blood clots
- Allergic reactions
- Instability and loosening
- Decreased range of motion
- Fractures of the bone around the knee replacement
Evidence of Attune Knee System Complications
Depuy Synthes has filed numerous reports with the FDA documenting the premature failure of the Attune knee system, citing destabilisation in the patient’s knees and the requirement for revision surgery.
In an article published in the Journal of Knee Surgery, nine prominent orthopedic surgeons reported that they have encountered an unusually high-rate of premature failures of the Attune Knee System. They said the failure was caused by the debonding of the tibial implant-cement interface, which leads to the tibial component loosening and the entire knee replacement becoming destabilized.
In most cases, the only medical solution for patients who experience a premature failure of their Attune Knee System is to undergo a revision surgery to remove the implant and replace it. These revision surgeries are often more painful and invasive than the initial replacement surgery.
In July 2015, the FDA issued a recall for over 3000 Attune Knee Tibial Articulation Surface instruments. The recall revealed the potential for the parts of the knee replacement components (the Baseal–a small wire spring coil which secures components of the knee) to become damaged and disassociate (come off). By June 2017, the FDA had received around 1400 reports involving failure of the Attune Knee System–including 633 cases where patients had needed revision surgery.
Last Edited: March 26, 2018
- Depuy Orthopaedics. (n.d.). DePuy Implant Advancements (including The Attune Knee System). Retrieved from http://www.kneereplacement.com/DePuy_technology/DePuy_knees
- Watson, S,(2016) Medical News Today: What are the Risks of Knee Replacement Surgery? (2016, May 18) From: https://www.medicalnewstoday.com/articles/310636.php
- Greengard, S. (2015). Risks and complication of total knee replacement surgery. (2015, February 20) From: http://www.healthline.com/health/total-knee-replacement-surgery/risks-complications
- Johnson & Johnson. (2014, March 12). Depuy Synthes Joint Reconstruction Introduces Two New Knee Technologies For The ATTUNE® Knee System. Retrieved from https://www.jnj.com/media-center/press-releases/depuy-synthes-joint-reconstruction-introduces-two-new-knee-technologies-for-the-attune-knee-system
- U.S. Food and Drug Administration (August 2010) Summary of Safety and Effectiveness https://www.accessdata.fda.gov/cdrh_docs/pdf10/k101433.pdf
- U.S. Food and Drug Administration (2015) Class 2 Device Recall ATTUNE Articulation Surface (2015, July 20) From: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137734
- US National Library of Medicine. Journal of Knee Surgery Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant-Cement Interface J Knee Surg 2017; 30(05): 435-439 DOI: 10.1055/s-0037-1603756. From https://www.thieme-connect.com/products/ejournals/pdf/10.1055/s-0037-1603756.pdf
- Malik S, The Legal Examiner (2018) DePuy Attune Knee Failures (2018, February 14). From: http://fortworth.legalexaminer.com/medical-devices-implants/depuy-attune-knee-failures/
- Densford F (2017) Mass Device. Report: DePuy Attune knee seeing unusually high rate of early failure. (2017, September 18). From: https://www.massdevice.com/report-depuys-attune-knee-seeing-unusually-high-rate-early-failure/