Knee replacement, also known as knee arthroplasty, is an invasive surgery. While patients may see increased mobility and a reduction in joint pain, knee replacement implants are also associated with risks, including device failure.

There are a variety of reasons a knee arthroplasty may fail. Some common ones are wear and tear on the replacement, infection after the surgery, fracture to bones around the knee implant, instability because of weakness in the surrounding tissue, and stiffness due to loss of range of motion around the device.

Defectively designed knee replacements have been blamed for many knee arthroplasty failures. Two devices that have reportedly failed at higher than normal rates are the Exactech Optetrak and the Arthex iBalance devices.

About the Exactech Optetrak Knee Replacement Device

The Exactech Optetrak knee replacement is designed with two plastic trays on the tibial side of the implant into which the femur side of the device moves.

Patients claim that the tibial trays wear out sooner than they should and that the tibial trays fail to properly connect to the rest of the tibial side of the implant, causing movement difficulty and pain.

Movement difficulty and pain have also been blamed because the tibial plate can loosen from the tibial bone in which it was implanted, causing the pieces of the device to fit together improperly.

Symptoms stemming from problems with a knee replacement, such as those reported with the Exactech Optetrak, include the following:

• Change in component position
• Disassociation of implant
• Fractures
• Infections
• Inflammation
• Instability problems
• Loosening of implant
• Mobility issues
• Pain
• Patello-Femoral Tracking-Lateral Release (kneecap moves out of place)
• Swelling
• Others

Information on Exactech’s Optetrak knee replacement alleged design defect was gathered in a study by Orthopaedics & Traumatology: Surgery & Research. The study examined the device’s performance at several time periods after surgery. A number of patients in the survey reported poor performance of the device.

The study reports included the following:

• 15 percent of patients were disappointed or dissatisfied with how the device performed
• 21 percent of patients showed signs of two parts of the device not fitting together as they should
• 22 percent of patients experienced pain that required painkillers on a regular basis
• 22 percent experienced the beginning signs of the title implants loosening

About the Arthrax iBalance Knee Replacement Device

The iBalance knee replacement device was marketed to provide an alternative to a complete knee replacement. It is designed to treat degeneration from conditions like osteoarthritis or post-traumatic arthrosis. Like many full knee replacement devices, the Arthrex is made with a tibial tray that fits over a tibia, and another component that moves against it.

The device was put on a fast-track FDA approval process in 2013, so it was not subject to the same testing as other devices. Its advertising centered on how its design differed from other devices on the market and reduced the need for subsequent surgeries to remove plates and screws.

Though the Arthrex iBalance offered an alternative to a full knee replacement, it was the subject of repeated complaints, possibly due to a design defect.

In December 2015, Arthrex issued a recall for the iBalance tibial tray after it was discovered that two of its components could be incompatible with one another.

The Arthrex website advertises the iBalance as a device that “provides a predictable, balanced result that provides near natural kinematics of the operative compartments,” a statement seemingly at odds with the device’s reported failures. 

Reportedly, the Arthrex iBalance TKA tibial tray had a smooth texture, when it was supposed to have a rough texture, making it incompatible with the rest of the knee system.

News about the device’s problems came as a disappointment to patients who looked to the Arthrex system to reduce the need for subsequent surgeries to remove metal plates and screws. 

Like the Exactech device, the alleged problem with the Arthrex iBalance  necessitated multiple revision surgeries in patients who had been fitted with the device.

The recall was voluntary and affected more than 2,300 tibial trays. Medical providers were asked to return any non-implanted tibial trays to Arthrex to ensure  that they were taken off the market and did not end up in any more knee replacements.

Following the voluntary recall, however, the FDA announced that the Arthrex iBalance TKA Tibial Tray would be removed from the market.

The Arthrex iBalance TKA tibial tray was associated with a range of serious issues and side effects, including:

• Severe pain
• Inflammation
• Reduced mobility
• Infection
• Bone damage
• Nerve damage
• Disassociation of the insert
• Loosening
• Hyperextension
• Knee instability
• Total knee replacement failure

Revision Surgery After Knee Arthroplasty Failure

Patients who had revision surgery after receiving an Arthrax device reportedly may suffer severe and permanent injuries, even after the device has been replaced. These subsequent surgeries pose a higher risk of complications and infection than initial knee replacement surgeries.

Revision knee replacement surgery patients also had elevated risks of experiencing poor tracking and having the device perform more poorly than those who just had the initial knee replacement surgery. In some cases, the issues with revision surgeries are identical to those that plagued patients before the initial knee arthroscopy.

In addition to physical injuries, patients who suffer knee replacement failure and then undergo subsequent revision surgeries often incur financial hardship because of medical costs, lost wages due to missed work, and more.

Most knee replacements are successful, however, some 20 percent of patients “may still experience pain following surgery for months or even years,”according to Dr. Amar Ranawat of New York City’s Hospital for Special Surgeries.

Even though a knee replacement patient may not have acute complications immediately after surgery, or even in the months afterward, complications could arise months or years later, requiring revision surgery.

Numerous patients have undergone revision surgeries to correct problems with these devices, sometimes to replace the entire knee implant, other times for just a part of the device.

Some patients claim that the Exactech Optetrak device caused double injury: Once when the device was implanted in their bodies, the other when they had to undergo painful and risky revision surgery.

When a knee arthroplasty fails, revision surgery may be the most effective way of helping patients recover from a failed knee replacement. Many patients who experienced complications from the Exactech knee implant have required revision surgery to correct tibial plate loosening, or to replace the device altogether. 

Lawsuits Over Optetrak, Arthrax iBalance Device Failure

Some patients are fighting back against defective and dangerous medical devices by filing lawsuits against the manufacturers. 

In the case of the Optetrak device, patient argue that its maker, Optetrak, did not sufficiently warn patients of the possible design defect or the dangers that may be associated with it.

Plaintiffs claim that because the device was fast-tracked for FDA approval, it did not go through rigorous enough testing before being placed on the market. Though Optetrak’s knee arthroplasty implant was advertised to the FDA as being “substantially similar” to other devices on the market, its differences posed a serious danger to patients that went unchecked before the device hit the market. 

Patients argue that Exactech knew or should have known that the Optetrak device was prone to failure but did not sufficiently warn patients, putting them in danger.

Arthrex has also faced legal action due of failures of its iBalance implant. Patients have alleged that the iBalance possesses dangerous defects and fails prematurely. 

Join a Free Knee Replacement Class Action Lawsuit Investigation

If you or a loved one suffered from complications caused by an Arthrex knee implant or an Exactech knee implant, you may have a legal claim. Get help now by filling out the form on this page for a FREE case evaluation.

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