For most patients, the new knee they received during knee replacement surgery should last for around 20 years. However, some find that isn’t true.

DePuy Orthopaedics, Inc. has recalled a component of the Attune knee implant called the “balseal” — a small wire spring — that has potential to detach and lodge itself in the surgical site, unbeknownst to patients. The recall affects approximately 3,500 units.

DePuy has found itself at the center of recall news in the past several years. In a 10-year period of time, from 2003 to 2013, the top six knee implant makers in the world recalled over 700 models of knee implants. This has affected many thousands of patients.

Of those recalled implants, 38 percent of these recalls were of devices manufactured by DePuy. DePuy is the second largest knee implant manufacturer in the world.

With their recent venture to redesign their knee implant systems, DePuy developed the Synthes Attune Knee System. The development of this new medical device took six years and it was the largest research and development project in the history of the company.

The features of the Attune were supposed to be superior to previous knee systems manufactured by DePuy:

• The Attune gradius curve provides a range of motion increasing stability,
• An s-curve design helps with stability when the patient bends or moves,
• The Logiclock Tibial Base is a locking base that reduces wear, and
• Glideright Articulation aids in soft tissue interaction and keeps the patella in place when the knee bends.

However, patients began to report problems with their Attune Knee System, which in 2015, prompted the recall of the balseal.

Patients have reported loosening or instability of the implant, heat or warmth in the knee, swelling around the knee joint and joint pain. They have also reported nerve damage, decreased range of motion, clicking or grinding sounds while walking and infection.

More serious reports of Attune knee system include fracture of the device components, fracture of the femur and/or tibia, device dislocation and misalignment of implant components. Also, tibial subsidence and metal shedding debris have been cited as causing problems. Many patients experience a need for revision surgery.

DePuy Attune Knee Component Recall

In 2015, the U.S. Food and Drug Administration announced a Class II recall for a component of the DePuy Attune knee replacement system. A Class II recall is a recall for a device that may cause temporary or medically reversible negative health consequences.

In this recall, the FDA discovered that the balseal which is small wire spring coil attached to the post feature of the Attune Knee Tibial Articulation Surface Instruments used in trialing may come off. If this happens, it may lodge itself in the surgical site if the surgeon does not know it has come apart.

If you or someone you love has been affected by the recall of this DePuy Attune knee component, you may benefit from speaking with an attorney experienced in medical device litigation.

While monetary compensation cannot take away the pain and suffering that may have accompanied a failed DePuy knee implant, it can help alleviate the cost of lost wages and medical expenses.

Get a Free Knee Replacement Case Review

If you or a loved one suffered from complications caused by an Attune knee implant, an Arthrex knee implant, or an Exactech knee implant, you may have a legal claim. In general, knee replacement surgery lawsuits are filed individually by each plaintiff and are not class actions. Get help now by filling out the form on this page for a FREE case evaluation.

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