Exactech Knee Liners

What Are Exactech Knee Liners?

Knee replacement implants have multiple parts, including a liner. The liner goes between parts of the implant.

Exactech manufactures multiple brands of knee replacement implants and liners. Brands include: ⁽¹⁾

• OPTETRAK® knee replacement systems.
• OPTETRAK Logic® knee replacement systems.
• OPTETRAK ® Patella devices. (recall notice dated 4/18/2024).
• TRULIANT® tibial inserts and components for primary and revision surgeries.

The company has voluntarily recalled numerous knee models due to defective polyethylene implant liners. ⁽²⁾

The company’s polyethylene liners can degrade prematurely. This degradation can lead to early device failure.

Complications and Side Effects

When you get joint replacement surgery — whether it is for a knee or hip — it is supposed to last for decades.

In this case, the Exactech implants are not meeting those standards. Instead, knee joint replacements patients are suffering from serious injuries due to the recalled implants and must have them prematurely removed with revision surgery.

Exactech has reported these kinds of complications: ⁽³⁾

• Statistically significant higher and earlier than expected revision rates in Optetrak TKR.
• Premature polyethylene (plastic) wear.
• Potential development of osteolysis (bone loss) in the first-generation Optetrak TKR.

In addition, “Polyethylene wear can initiate a variety of clinical issues.” ⁽⁴⁾ This includes:

• Device loosening.
• Device fracture.
• Mechanical failure.
• Pain.
• Bone loss.
• Recurrent swelling in the affected area.

What Did Exactech Recall?

Exactech has issued a recall of all its “total knee, partial knee, and ankle devices with plastic inserts packaged in the non-conforming bags with the missing layer of EVOH.” ⁽⁵⁾

If you are suffering any of the symptoms or diagnoses indicated, you may have been implanted with a defective device. In many cases, you don’t know the brand of total knee replacement or partial knee replacement insert used in your procedure. Even fewer patients know the identifying serial number of the implant in your body.

If you suspect you received a recalled implant, you can contact the surgeon who performed your procedure. They should be receiving details about the recalled devices. Surgeons were supposed to send out letters advising patients of the recall, but surgeons may have retired or moved or you may have moved and did not receive a letter sent to your old address.

What Is a Recall?

A recall is a way of “removing or correcting products” violating laws the FDA oversees. A “recall is a voluntary action” that takes place to protect the public health “from products that present a risk of injury or gross deception or are otherwise defective.” ⁽⁶⁾

A manufacturer or distributor of a defective product can voluntarily initiate a recall at any time. Sometimes the FDA steps in and requests the manufacturer or distributor issue a recall. ⁽⁷⁾

When the FDA instructs a company to recall a product, the situation is considered urgent. The FDA directs “the firm that has primary responsibility for the manufacture and marketing of the product” to issue a recall. ⁽⁸⁾

Although the FDA may initially clear an orthopedic medical device for manufacturing and distribution in the U.S., the agency keeps an eye on how the devices are working among real people. The agency collects adverse events reports and maintains a database about potentially defective products. Sometimes, recalls are necessary, and the FDA acts to prevent further harm.

Data from Australia

Data from other countries which have single payor health systems, enabling their regulatory authorities to track implants and their failure or revision rates, is even more informative. The Australian Orthopaedic Association National Joint Replacement Registry did an analysis that compared the Optetrak-PS/Optetrak-PS femoral/tibial combination with all other total knee prostheses. It found, “This combination has been identified as having a significantly higher rate of revision.” ⁽⁹⁾

New FDA Knee Approval May Indicate Defects in Recalled System

Exactech applied for FDA clearance for a new knee polyethylene tibial insert. The manufacturer announced they received it on August 22, 2023. The new component is called the Activit-E polyethylene (PE). It contains a vitamin E antioxidant. That means it does not require gamma sterilization. The previous formulations of the material did. ⁽¹⁰⁾

This new product is intended to replace the recalled one. Exactech claimed the old polyethylene liner was acceptable to continue to use, when it had the proper packaging.

However, the creation of this new implant implies that issues in addition to the packaging were behind the need for the recall. We believe there were concerns at Exactech over additional problems with the polyethylene liner formulation and manufacturing itself.

Filing an Exactech Lawsuit

Weitz & Luxenberg has filed numerous cases on behalf of clients injured by Exactech knee failures in various federal courts. In June 2022, our attorneys filed a petition with the Judicial Panel on Multidistrict Litigation to create the multidistrict litigation (MDL) for Exactech’s defective polyethylene inserts. The request covered the inserts used in knees, hips, and ankles. It was approved on October 7. The MDL is No. 3044 – In re: Exactech Polyethylene Orthopedic Products Liability Litigation in the Eastern District of New York in Brooklyn. W&L partner, Ellen Relkin, is the co-lead counsel. Ms. Relkin is chair of our Drug and Medical Device Litigation team. Attorney Danielle Gold is a member of our team. She is serving on the Science and Experts subcommittee.

Because many thousands of these devices have been implanted, it’s possible the legal cases may number in the thousands. The number of complaints has continued to rise as patients who receive the recall notice go to their doctors for evaluation. These patients are given X-rays, MRIs — and even a procedure called an aspiration — to evaluate the state of their Exactech knees. From the procedure results, patients are learning their prosthesis has loosened, the inserts have degraded and shredded, there is polyethylene debris in the fluid around the knee, and that they need revision surgeries.

Your device may have loosened prematurely. Your surgeon may have performed a revision surgery already or may have recommended you undergo a revision surgery. These are more complex than primary surgeries and typically require more extensive treatment, follow-up, and physical therapy.

Choosing W&L for Your Lawsuit

As of June 2022, W&L attorneys with offices in New York, New Jersey, California, and Michigan, have already filed multiple lawsuits in federal and state courts against Exactech for this issue. We are encouraging patients who received these defective implants to reach out to us if your implant has failed.

Contact our attorneys at W&L by filling out the form on this page or by calling us at (833) 977-3437. You can get a consultation from us for free.

Once you have hired the attorney who is right for you, you are guided you through all the necessary legal steps. Your attorney can discover if you may be able to join the litigation already beginning.

W&L Successful Lawsuits for Defective Joint Implants

W&L attorneys have been handling complex, national litigation involving defective drugs and medical devices for almost four decades. Over the years, we have been awarded more than $19 billion dollars on behalf of our clients.

It is our mission to fight against companies marketing and distributing defective products and endangering people’s lives. These companies may be out to make as much money as possible, but we have dedicated ourselves to standing up to them if you have been harmed. We are holding them accountable for the damage they have caused you.

Here are a couple examples of our defective orthopedic implant victories:

• $1 billion+ – W&L negotiated this settlement with Stryker on behalf of roughly 3,000 patients who were injured by the company’s Rejuvenate and ABGII modular hip implants.
• $2.5 billion – W&L secured this settlement with DePuy on behalf of thousands of patients who received the company’s defective ASR hip implants.