Individuals who underwent knee, hip, and ankle joint replacement with Exactech devices may be at risk for premature failure of these implants.  

Exactech recently notified surgeons that it is recalling all of its knee and ankle polyethylene inserts packaged in non-conforming plastic bags. These non-conforming bags may allow oxygen into the package, resulting in damage to the insert that could lead to implant problems and failures. 

Previous recalls concerning similar polyethylene inserts used with Exactech’s Connexion hip implants have indicated similar problems. These inserts, as well, were packaged in defective vacuum bags, and hip implants with these liners have shown high rates of early failure. 

The defective product liability lawyers at Chaffin Luhana are currently investigating cases in which patients were implanted with Exactech devices and then had to undergo risky revision surgeries to fix or replace them. 

Give our experienced team call today to schedule a complimentary consultation at 1-888-480-1123. 

What Is the Exactech Recall? 

Exactech—a global medical device company headquartered in Gainsville, Florida—has manufactured joint replacement devices for over 30 years, selling hundreds of thousands of them in the United States while touting their safety and effectiveness. Over the past couple of years, however, the company has implemented several recalls of its implants because of reports they were failing sooner than expected.  

The problem is with the polyethylene liners. These are plastic inserts that fit between the metal components in knee, hip, and ankle replacements. They are sometimes called “shock absorbers” and serve as cushioning replacements for the cartilage in the joints. If these inserts fail, the joint replacement fails. 

Exactech’s most recent recall involves its knee and ankle replacements. On August 30, 2021, it notified doctors and healthcare centers about a possible problem with its polyethylene inserts.  

Some of these inserts had been packaged in vacuum bags that “lacked an additional oxygen barrier layer.” This could increase the risk that the insert would be exposed to oxygen, which could induce oxidation.  

When you set a sliced apple out on the table, it turns brown in a short time. That is oxidation. The elements in the apple interact with oxygen in the air, creating that brown color. The same occurs when iron interacts with oxygen to create rust. The interaction between components in the metal and oxygen is destructive and damaging.  

Oxidation can also occur when polyethylene (plastic) inserts are exposed to oxygen. Components in the insert can interact with the oxygen, creating oxidation and damage. This may cause the plastic to wear out earlier than expected or to become damaged after it is implanted into the patient’s body.  

Premature wear of this nature can lead to the need for additional (revision) surgery in some patients.  

At the time of that first recall warning, Exactech removed all knee and ankle products labeled with an 8-year shelf life and not packaged in the correct bags. The company urged doctors to avoid using these devices and return them to Exactech.  

The recall included only the OPTETRAK Comprehensive Knee System, including OPTETRAK All-polyethylene Tibial Components not sold in the USA.  

Why Did Exactech Expand Its Recall? 

After additional testing on these products, Exactech announced that most of these inserts manufactured since 2004 had been packaged in these non-conforming bags.  

In a second urgent medical device correction letter to healthcare providers, the company announced that it was expanding its previous recall to include “all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of shelf life.” For those devices already implanted, the company provided surgeons with guidelines on how to follow up with their patients.  

Polyethylene inserts packaged in non-conforming bags could be subject to “increased oxidation of the material,” Exactech explained. Over time, oxidation “can severely degrade the mechanical properties” of the insert, which, in conjunction with other surgical factors, “can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.” 

The recalled inserts may be associated with the following risks: 

• Increased risk of polyethylene (plastic) wear 
• Potential development of osteolysis (bone loss) 
• Significantly higher and earlier than expected revision rates 

Exactech noted that reasons for revision potentially associated with polyethylene wear were increased three- to seven-fold in its Optetrak TKR (total knee replacement) insert when compared to other similar devices, potentially because of the non-conforming packaging.  

These data were discovered during an examination of the Australian Registry, which contains information on joint implantations and revision surgeries. Out of 3,684 Optetrak TKRs, there were 374 revision procedures. This was a higher rate compared to other similar replacement systems.  

Data from the United Kingdom Registry and the New Zealand Registry showed similar results, with Optetrak systems having a higher revision rate than other knee replacement systems. 

What Systems Are Recalled? 

Devices affected by this expanded recall include: 

• OPTETRAK Tibial Inserts (introduced in the U.S. in 1994) 

• OPTETRAK Logic Tibial Inserts (introduced in the U.S. in 2009) 
• TRULIANT Tibial Inserts (introduced in the U.S. in 2017) 
• VANTAGE Fixed-Bearing Liner Component (Introduced in the U.S. in 2016) 

In total, this expanded recall affected nearly 150,000 devices.  

Problems with Exactech Hip Replacement Devices  

In addition to this issue with the plastic inserts, Exactech has faced similar problems with some of its hip replacement devices as well.  

Back in June 2021, Exactech recalled over 80,000 of the polyethylene liners used in its Connexion GXL hip implants, stating they could lead to “premature wear.” At the time of the recall, the company was aware that its hip replacement implants with these liners were showing high rates of early failure.  

After investigating the issue further, Exactech found that these liners—like those used in knee and ankle implants—were shipped in defective vacuum bags that could expose them to the air. Oxygen could pass through the bag, creating oxidation and damaging the liner.  

This could cause the insert to degrade before being implanted in a patient, leading to premature wear and an increased risk of early implant failure. 

In a 2020 study, researchers reviewed data on patients who went through hip replacement surgeries between January 2009 and June 2019 at the Department of Orthopedics and Rehabilitation at the University of Florida College of Medicine.  

They discovered that the Exactech Connexion GXL liner “may be prone to a high rate of early failure from wear and severe secondary osteolysis. We recommend close surveillance of patients with this bearing surface.” Osteolysis is a condition where bone tissue is destroyed. 

In another study that same year, researchers noted a “concerning trend” with the use of the Exactech Connexion GXL liner. Patients examined in the study demonstrated early wear of the liner. The researchers noted that further investigation was warranted to “evaluate material characteristics which may have caused this accelerated wear and to prevent recurrences of this complication in the future.” 

Common Joint Replacement Complications 

If something goes wrong with a knee, ankle, or hip replacement, it can cause symptoms like the following:  

• Pain 
• Grinding sensation 
• Joint beginning to lock up 
• Stiffness 
• Reduced range of motion 

• Swelling, redness 
• Loss of mobility 
• Instability or trouble balancing 
• Trouble getting up from a seated position 
• Popping or clicking sounds when walking 

If the problem continues to get worse, leading to eventual implant failure, the following complications may occur: 

• Inflammation and redness 
• Severe pain 
• Tissue and bone damage 
• Muscle damage 

• Loosening of the implant 
• Disassociation of the insert  
• Infection 
• Change in position of the components 
• Joint replacement failure 

• The need for joint replacement surgery 

Are You In Need of Revision Surgery? 

Revision surgery is a type of surgery performed on a patient who has already had prior joint replacement surgery. It is done to either fix a problem with that implant or to replace it completely.  

One of the most common reasons for revision surgery is that the existing implant has reached the end of its expected lifespan, which is about 15-20 years for most artificial joints. Faulty implants, however, may fail much before that, sometimes after only a few years.  

Depending on what’s wrong, the surgery may remove some or all parts of the original implant and replace them with new ones. Revision surgery, by its very nature, is riskier than the original surgery. It takes longer, is more complex, and requires extensive planning as well as specialized implants and tools.  

Surgeons have to take into account any damage that may have been done by a faulty implant, including tissue damage and death, muscle damage, infection, and bone loss. The bone may need to be rebuilt with augments or bone graft.  

The surgeon may also need to use a specialized implant with longer, thicker stems that fit deeper inside the bone for extra support. In some cases, patients may need to undergo more than one surgery to complete the procedure. 

If you experience any of the symptoms mentioned above—like stiffness, grinding, instability, pain, or loosening—talk to your doctor. He or she will order imaging tests to examine the condition of your implant.  

X-rays can show how the bone is doing, while other imaging tests like an MRI (magnetic resonance imaging) or CT scan (computerized tomography) will help your doctor determine whether the implant has failed and if so, why and what needs to be done. 

Your doctor may also order blood tests to check for possible infections or toxins that may have been shed from the implant components.  

If you’re facing revision surgery because of a faulty implant, the Exactech recall lawyers at Chaffin Luhana are standing by to help. We have been successful at obtaining significant awards in medical device lawsuits and want to help you gain the compensation you deserve.  

You will need to focus on healing and getting back to your life—you won’t want to worry about medical expenses as well. A successful Exactech lawsuit can give you the peace of mind you need to know that your medical treatments, as well as other things like lost wages and pain and suffering, will be taken care of.