Patients who received a total hip, ankle, or knee replacement with components or inserts manufactured by Exactech may experience problems with their implant. Some patients have had to undergo painful revision surgeries to replace recalled components.

If you or a loved one is experiencing side effects of a total hip, knee, or ankle replacement, such as pain or limited mobility, it’s critical to see a doctor and contact an attorney who specializes in personal injury cases as soon as possible to determine whether you qualify for an Exactech lawsuit.

A hip replacement implant contains several different parts, including:

• A metal cup (called an acetabular component)
• A spherical ball (called a femoral head), which is inserted into the metal cup
• A liner that goes in between the metal cup and the spherical ball

In June 2021, Exactech issued an urgent letter to orthopedic surgeons warning of the failure rate of the Exactech Connexion GXL polyethylene liner used in total hip replacements.

The GXL liner was removed from the market in 2019 and replaced by a new product (the XLE liner). But by that point 90,000 GXL liners had already been implanted in patients.

What Are the Symptoms of an Exactech Hip Failure?

Your surgeon may contact you if they are concerned about the implant you received. However, don’t wait for a call from your surgeon, especially if you are experiencing any of the following symptoms:

• Pain
• Stiffness
• Limited mobility or range of motion
• Loosening of the hip joint

If you received an Exactech Connexion GXL liner, it doesn’t necessarily mean you will need revision surgery. But if you are experiencing symptoms associated with excessive wear of the liner, you should see your doctor right away.

Exactech Knee & Ankle Implant Recall

There are four artificial parts that make up a total knee replacement:

• The femoral component, a metal piece that attaches to the thigh bone
• The tibial tray, a metal piece that fits into the shin bone
• The patellar component, a plastic piece that fits over the kneecap
• The tibial polyethylene insert, a plastic insert that fits between the femoral and tibial components and cushions the knee joint

There are three artificial parts that make up a total ankle replacement:

• The tibial component, a metal piece that attaches to the shin bone
• The talar component, a metal piece that goes into the talus bone in the foot
• The polyethylene insert, a plastic insert that fits between the tibial and talar components and cushions the ankle joint

Exactech first issued a limited recall of their knee and ankle arthroplasty polyethylene inserts in August 2021 after finding defective packaging for these components.

In April 2022, the company issued an urgent letter to physicians expanding on the earlier recall.

Extensive testing confirmed that around 80% of inserts manufactured since 2004 were packaged in a way that could allow the polyethylene plastic liners in the knee and ankle replacement devices to wear down prematurely.

This can lead to injury after the device is implanted in the patient’s body, which may ultimately require revision surgery to correct.

What Knee and Ankle Components Are Part of the Exactech Recall?

The most recent Exactech joint replacement recall includes all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming vacuum bags regardless of the label or shelf life of the device.

Here is a list of affected devices:

• OPTETRAK® All-polyethylene Tibial Components (TKR & PKR)
• OPTETRAK® Tibial Inserts (TKR)
• OPTETRAK® HI-FLEX® Polyethylene Tibial Inserts (TKR)
• ARTHROFOCUS® Polyethylene Tibial Inserts (TKR)
• OPTETRAK® Custom Polyethylene Tibial Inserts (TKR)
• OPTETRAK® LOGIC® Polyethylene Tibial Inserts (TKR)
• OPTETRAK® RBK® Polyethylene Tibial Inserts (TKR)
• TRULIANT® Tibial Inserts (TKR)
• OPTETRAK® Logic RBK Tibial Components (TKR)
• Vantage® Fixed-Bearing Polyethylene Liner Component (TAR)
• Vantage® Mobile-Bearing Polyethylene Liner Component (TAR)

If you’re not sure whether the Exactech recall applies to your specific implant, contact your medical provider’s office. The surgeon will check to see if the serial number of your component is included in the list of affected devices provided by Exactech.

What Are the Symptoms of an Exactech Knee or Ankle Failure?

Symptoms of a problem with a knee or ankle replacement device can include:

• Pain while walking
• Swelling in the ankle
• Inability to bear weight
• Grinding, clicking sounds, or other noise
• Instability on the affected knee or ankle

If you are experiencing these or other symptoms, contact your doctor right away. Your surgeon may examine you and take x-rays to determine the condition of your knee or ankle replacement device.

How Serious Is Revision Surgery?

All surgeries are serious, and hip, knee, and ankle revision procedures are no exception. Revision surgery can take several hours, depending on the cause of the implant failure.

Revision surgeries can be even more complex than the initial joint replacement surgery, requiring extensive planning to remove and replace the faulty components of the original implant.

Possible risks that come with revision surgery include:

• Infection
• Poor wound healing
• Excessive bleeding
• Anesthesia complications
• Damage to blood vessels or nerves
• Heart attack or stroke during surgery
• Bone fractures or bone loss

What to Do If You Need Revision Surgery

If you need revision surgery, your surgeon may refer you to the Exactech-Broadspire Helpline to initiate a claim.

Exactech has retained Broadspire, an insurance company, to manage their settlement claims. It’s important to know that Broadspire represents the interest of Exactech—not patients.

The Exactech-Broadspire settlement will only reimburse you for out-of-pocket expenses related to the revision surgery. But you may be entitled to more compensation for damages like pain and suffering, lost wages, and related medical expenses.

This is why you should speak with an experienced personal injury attorney about your case before contacting the Exactech-Broadspire Helpline.

Why Are People Filing Exactech Recall Lawsuits?

Exactech is accused of using inadequate packaging for its knee, ankle, and hip implants. The controversy is linked to the absence of an oxygen barrier layer on the packaging that contained these products. Polyethylene (plastic) components, which are found in a variety of medical devices, are prone to oxidation—that is, degradation of the material due to contact with oxygen. If these kinds of medical components are exposed to oxygen while in storage, they might suffer premature damage that can interfere with their capacity to perform according to their intended purpose. By incorporating one or more oxygen barrier layers on packaging, manufacturers can prevent oxidation from harming their medical devices before these products can reach the consumer.

A large number of Exactech products were packaged without one of the necessary protective oxygen barrier layers. As a result, the components began deteriorating while in storage. Many persons who received one of these damaged implants later reported pain or discomfort that can be directly linked to oxidation of the device.

Oxidized polyethylene implants are more likely to fail years earlier than their normal lifespans, necessitating surgery to remove or replace the component. These impaired devices can also deteriorate and spread tiny fragments into the soft tissue of the surrounding area of the patient’s body. This can result in necrosis (cell death). Other potential complications include osteolysis (loss or destruction of bone tissue) and fluid buildup around the affected joint.

In June 2021, Exactech issued a voluntary recall on some of its hip replacement devices. In February of the following year, the company announced a recall on its Optetrak, Logic, and Truliant knee replacement devices as well as its Vantage ankle replacements. All these actions were classified as Class II recalls by the Food and Drug Administration (FDA), which indicates products that pose a moderate degree of risk to the consumer. Health care providers have been advised to avoid using any recalled Exactech devices in surgical procedures and to remove these products from their inventory and return them to the manufacturer.

In total, several hundred thousand Exactech knee implants, ankle implants, and hip implants are subject to the recall. Devices affected by the recall were manufactured from 2004 to August 2021. There is an ongoing FDA investigation to determine whether the recall should be expanded to include other Exactech devices.

Not everyone who received an Exactech implant has experienced pain or any of the other complications commonly associated with these devices. For these fortunate individuals, the FDA does not at the present time recommend surgery to remove the device. However, many people have experienced adverse physical reactions from their Exactech implant. These persons trusted Exactech implants to provide relief for osteonecrosis, osteoarthritis, rheumatoid arthritis, or another condition that impedes physical mobility, and they may qualify for financial compensation due to suffering caused by the manufacturer’s failure to ensure an acceptable level of device safety.

Under U.S. law, manufacturers can be liable for product defects that result in harm to the end user. This can include defects that arise due to improper packaging. Exactech has been accused of knowing about the defective packaging and failing to take appropriate steps to remediate the issue.

Individuals who have experienced physical harm may be eligible to collect financial compensation from Exactech for lost wages, pain and suffering, and/or medical expenses connected to the defective implant.

If you believe you or someone close to you has been harmed by an Exactech implant, it is important to contact a qualified attorney who can guide you through the process of obtaining compensation. One of the keys to maximizing your chances of success is to work with a lawyer who understands the various factors that go into determining payouts for manufacturer negligence. 

How Much Can I Get in an Exactech Lawsuit?

Looking at past settlements and verdicts can help attorneys determine the potential value of a client. However, each case is different.

The severity of your injuries and the specific circumstances surrounding your case are important factors that will help determine possible compensation amounts.

Get Help from Experienced Personal Injury Attorneys

Patients who undergo knee, ankle, or hip replacement surgery put an incredible amount of trust in their surgeons—and in the medical device companies that manufacture implants. When something goes wrong, it’s a breach of trust.

No one should have to live with unnecessary pain or injury because of a faulty or defective medical device. If you or a loved one has been impacted by an Exactech hip recall, Exactech knee recall, or Exactech ankle recall, we can help determine whether you have a product liability lawsuit.

The personal injury attorneys at Saunders & Walker P.A. have decades of combined experience handling medical device cases. We’ve won millions for our clients, and we’re ready to help you.

Get in touch for a free case review today or call (727) 579-4500 to find out if we may be able to help you or your loved one get justice.