Exactech® Knee Lawsuit | Exactech Knee Lawyer, Attorney

More than 140,000 Exactech knee implants were recalled because they can fail prematurely, causing severe pain and other problems that require revision surgery.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Exactech knee induced injury cases in all 50 states. If you or somebody you know was injured by a bad knee replacement or needed surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

2023 UPDATE: Exactech Facing Around 800 Lawsuits in MDL

As of June 2023, more than 775 lawsuits have been filed by people who were injured by Exactech joint replacements in the Multi-District Litigation (MDL No. 3044) in the U.S. District Court for the Eastern District of New York.

Most of the cases involve Exactech knee replacements, but there are also hundreds of lawsuits involving Exactech ankles, hips, and other joints that were recalled because they can fail prematurely. All of the lawsuits allege that “out-of-specification” vacuum-sealed bags allowed oxygen to reach the implants long before they were implanted in patients, which increases the risk of premature failure and revision surgery, often within just a few years.

Exactech Recalls 140,000 Knee Implants Sold Since 2004

In February 2022, Exactech issued a recall (PDF) for more than 140,000 knee and ankle replacement systems that were implanted in patients in the U.S. since 2004 because they can fail prematurely.

The problem is that the knee and ankle implants contained a plastic insert that was packaged in “out-of-specification” vacuum bags. This defective bag allowed oxygen to reach the plastic inserts before they were implanted in patients, causing the entire system to wear out much faster than expected.

Exactech warns that the problem can cause “severe damage” and other problems including:

“[The problem] can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.”

Due to the problem, patients may experience severe side effects, such as:

Knee pain, swelling or instability
Pain when walking
Unable to put weight on the knee/ankle
Knee grinding, clicking, etc.
Need for revision surgery

The recall impacts the following number of Exactech knee and ankle replacements:

Exactech Optetrak Lawsuit Filed Over Knee Implant Failure

October 2017 — A man who needed revision surgery because his Exactech Optetrak® knee replacement failed prematurely has filed a Lawsuit (PDF) in Alabama.

Many people have required revision surgery because the Optetrak loosened and failed prematurely, resulting in pain, limited mobility, knee swelling, and sensitivity due to loosening of the knee joint. Click here to read more.

What is the Optetrak Tibial Tray?

Exactech Inc., of Gainesville, Florida, has been selling knee implants for decades. The Exactech Optetrak® knee has been sold since 1994, but the company made slight design changes in 2011 and 2012 — with devastating results for patients. The new “finned” tibial trays have been linked to many reports of premature loosening, pain and failure.

Problems With “Finned” Tibial Trays

Experts believe the “finned” tibial tray does not promote adequate bonding between the patient’s knee bones and the Optetrak implant. As a result, Exactech switched to “fit” tibial trays in 2013. The problem is that patients who experience knee implant failure will need to have another surgery to remove and replace the defective components.

Knee Implant Complications

Knee pain
Swelling or fluid build-up
Inflammation
Loosening
Unstable knees
Trouble walking
Inflammation
Infection
Bone fracture
Muscle loss
Needing another surgery
Limited range of motion

Study: “Poor Results” of Exactech Optetrak Knees

Almost immediately after Exactech changed to the “finned” tibial tray design on the 2011 and 2012 Optetrak knee implants, researchers began warning about “poor results” and high rates of implant failure.

In a study of 110 patients over an average follow-up of 25 months, the researchers observed the following rates of serious problems:

15% of patients were disappointed or dissatisfied
22% were painful and required regular painkillers
22% were “evolving toward tibial implant loosening”
21% had signs of patellofemoral conflict
12% of patients needed another surgery within 5 years due to tibial loosening, instability, or pain

The study was published in February 2012 in the medical journal Orthopedics & Traumatology and titled: “Poor results of the Optetrak cemented stabilized knee prosthesis after a mean 25-month follow-up: Analysis of 110 prostheses.”

Exactech Knee Settlement

Exactech paid a $3 million settlement to the U.S. Department of Justice in December 2010 to resolve allegations of paying illegal kickbacks to doctors who used the company’s devices in hip and knee surgery.

2012: Exactech Optetrak Knee Recall

Exactech issued a Class II recall in July 2012 for Optetrak knees that may be mislabeled:

Optetrak Cemented Trapezoid Tibial Tray (Size 1F/1T, 2F/1T)
Optetrak Rotating Bearing Knee Tibial Tray, Finned (Size 2F/1T)

Do I have a Exactech Knee Lawsuit?

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Exactech Knee Lawsuit