If you’ve suffered pain or injury from a hip, knee, or ankle replacement surgery performed between 2004 and 2022, then read on - you may be entitled to compensation. As of February 2022, medical equipment company Exactech has recalled hundreds of thousands of medical devices due to defective polyethylene inserts. Exactech advertised these components as durable “ultra high molecular weight polyethylene.” Essentially, the inserts are plastic.

It is believed that defective packaging allowed the inserts to be exposed to oxygen, causing them to deteriorate much more quickly than expected both prior to and after implantation. This rapid deterioration of the liner in the body caused many devices to fail. These faulty components have remained in use between 2004 and February 2022, causing devastating ill effects in innumerable patients. Many of these patients have now taken legal action against Exactech.

HIP REPLACEMENT SURGERY AND ASSOCIATED CONDITIONS

The hip is a ball and socket joint. There are four ball and socket joints in the human body – each shoulder and each hip. Ball and socket joints allow the highest freedom of motion of all joints. The long bone in the thigh is called the femur, and the top of the femur is called the femoral head. In the hip joint, the femoral head sits inside the hip socket.

Doctors may recommend total hip replacement for individuals who suffer from osteoarthritis, rheumatoid arthritis, osteonecrosis (avascular necrosis) or trauma to the hip joint. Rheumatoid arthritis is a chronic immune disorder that can affect the hip joint. It develops from wear on the cartilage covering the bones of a joint. This condition can occur due to age or overuse, as well as from trauma. It can cause stiffness, pain, and lack of mobility in one or both hips. Common symptoms of rheumatoid arthritis include difficulty walking, joint pain and swelling.Osteonecrosis (or avascular necrosis) causes the death of bone tissue in the top of the femur due to a lack of blood supply. Associated with steroid and alcohol use, it is most common in people between the ages of 30 and 60.

Hip replacements can also be issued as a result of trauma, often through fractures, dislocation, or tearing of soft tissue around the hip joint. Hip replacement surgery is intended to alleviate pain in the hip joint and allow patients to regain their range of motion. Trauma to the hip can occur as a result of injury or overuse. Obesity is strongly associated with the need for a hip replacement, as excess weight causes excess wear and tear on the bone and cartilage of the hip joint.

EXACTECH LAWSUIT FOR DEFECTIVE HIP IMPLANTS - EFFECTS OF EXACTECH CONNEXION GXL LINERS

Exactech has recalled more than 100,000 hip replacement implants due to their defective Exactech Connexion GXL inserts. Defective storage allowed these plastic components to oxidate while still in their packaging. This exposure to oxygen caused the inserts to deteriorate. Rapid deterioration of these components within the body has caused the device to fail in numerous recipients of hip replacement surgeries, leading to the recall and subsequent lawsuits against Exactech.

In a total hip replacement surgery, the surgeon removes the natural femoral head and replaces it with a new femoral head. The new femoral head may be ceramic or metal. The surgeon will also place a new cup in the socket of the pelvis where the new femoral head will sit. This socket is called the acetabulum. The new cup is usually metal. Between the femoral head and the new cup in the pelvis the surgeon will place a polyethene, or plastic, liner to promote smooth hip articulation.

In the Exactech hip replacement implants, the Connexion GXL liner between the femoral head and the cup is believed to be deteriorating too quickly and causing the device to fail. As the polyethylene liner degrades, plastic debris invades the tissue around the hip. This polyethene debris is toxic to the soft tissue, muscle and bone surrounding the hip joint, leading to necrosis, or tissue death.

This tissue and bone death causes pain and dislocation of the hip joint. Patients report experiencing poor health effects from the defective Exactech liner, including pain, loosening, stiffness, and limited mobility. Ultimately, injured patients will have to undergo a painful revision surgery to remove the insert and treat the diseased tissue and bone.

On Exactech's website, you can see a list of the components that may have caused your replacement device to fail. The list includes Exactech GXL acetabular liner. These are sold under the names MCS, Novation and Acumatch.

KNEE REPLACEMENT SURGERY AND ASSOCIATED CONDITIONS

The knee joint is located at the bottom of the long bone in the thigh (the femur) and the top of the long bone in the lower leg (the tibia). The most common condition for which doctors recommend total knee replacement is osteoarthritis. This condition causes the breakdown of the cartilage within the knee. Once the cartilage deteriorates, the knee joint can become painful and limit the patient’s ability to walk. The surgery is intended to replace the deteriorated cartilage, alleviate pain, and allow patients to regain their range of motion.

Other conditions that often require a full knee replacement include rheumatoid arthritis, osteonecrosis, and trauma. Rheumatoid arthritis is a chronic inflammatory disorder where the body's immune system attacks its own tissue, including knee joints. Osteonecrosis (or avascular necrosis) causes the death of bone tissue in the talus due to a lack of blood supply. It is most common in people between the ages of 30 and 60, and is associated with steroid and alcohol use. Knee replacements can also result from trauma, including fractures, dislocation, and tearing of soft tissue around the knee. Trauma to the knee can occur as a result of accidents or overuse. Obese individuals are 40% more at risk for needing knee replacement surgery, due to extra pressure on the joint.

EXACTECH KNEE IMPLANTS - NEGATIVE EFFECTS OF EXACTECH POLYETHYLENE TIBIAL LINERS

Exactech has recalled over 100,000 knee replacement implants due to their defective polyethylene tibial inserts. The polyethylene components of the recalled Exactech devices were exposed to oxygen in defective storage conditions, causing rapid deterioration in patients’ bodies post implantation, with numerous negative effects.

In a total knee replacement surgery, the surgeon removes part of the natural femur above the knee joint and replaces it with a new metal femoral component. The surgeon will also remove part of the natural tibia bone and insert a metal tibial device. Between the femoral component and the tibial component, the surgeon will place a polyethene, or plastic, tibial liner to promote smooth knee range of motion and prevent metal on metal contact. This device acts as new “cartilage” within the knee joint.

Debris from the deteriorating Exactech polyethylene liner of the device invaded the tissue around patients’ knees. This polyethene debris is toxic to the soft tissue, muscle and bone surrounding the knee joint. This soft tissue, muscle and bone can grow necrotic as a result. Patients may suffer knee swelling, pain while walking, inability to bear weight on the knee, grinding or clicking, and instability as a result of defective tibial inserts. Ultimately, injured patients will have to undergo a painful revision surgery to remove the defective Exactech device and treat the diseased tissue and bone.

After the Exactech knee replacement recall, the company published a list of the medical components that may fail on its website. The list includes Optetrak and Arthrofocus tibial inserts.

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ANKLE REPLACEMENT SURGERY AND ASSOCIATED CONDITIONS

The ankle joint is located at the junction of the talus, tibia, and fibula bones of the lower leg. A full ankle replacement surgery may be necessary to address damage to the ankle caused by a variety of conditions, including rheumatoid arthritis, osteonecrosis, and trauma.

Rheumatoid arthritis is an inflammatory disorder that develops from wear on the cartilage covering the bones of a joint. This condition can occur due to age or overuse, as well as from repeated injury. Common symptoms of this disorder include difficulty walking, or swelling and pain in the joint. Osteonecrosis (or avascular necrosis) causes the death of bone tissue in the talus due to a lack of blood supply. It is most common in people between the ages of 30 and 60, and is associated with steroid and alcohol use.

Ankle replacements can also be issued as a result of trauma, often through fractures, dislocation, or tearing of soft tissue around the ankle. These conditions can damage the smooth cartilage around the ankle, causing pain and swelling. Ankle replacement surgery is intended to alleviate pain and allow patients to regain their range of motion. Trauma can occur as a result of injury or overuse. Obese individuals are at higher risk for needing ankle replacement surgery due to extra pressure on the joint.

EXACTECH DEFECTIVE ANKLE IMPLANTS - EFFECTS OF EXACTECH VANTAGE POLYETHYLENE LINERS

Exactech has recalled hundreds of thousands of its ankle replacement devices. The components in these devices - Exactech's Vantage polyethylene inserts - oxidized due to faulty packaging. This caused them to deteriorate more quickly than expected both prior to and after inserting the Exactech ankle replacement implant. This rapid deterioration of the insert between the tibia and the talus caused many devices to fail, leading to revision surgeries and a host of negative effects on individuals with the replacement.

In a total ankle replacement surgery, the surgeon addresses the damage to the bottom of the long bone in the shin (the tibia) and the top of the foot (the talus) and implants new components. The surgeon will also implant a polyethylene liner to promote smooth ankle-joint articulation. The Exactech ankle replacement devices were recalled because the debris from the deteriorating Vantage polyethylene liners invaded the tissue around patients’ ankles. This plastic debris is toxic to the soft tissue, muscle and bone surrounding the knee joint, and can cause it to grow necrotic and die. Patients with defective Exactech replacements implant have reported pain, inability to bear weight on their ankles, grinding noise in joints, swelling, and instability in the ankle. Ultimately, injured patients will have to undergo a painful revision surgery to remove the defective tibial implant and treat the diseased tissue and bone.

Exactech has published a list of the components that may fail on its website. The list includes Exactech Vantage polyethylene inserts.

RECENT LAWSUITS AGAINST EXACTECH FOR DEFECTIVE KNEE, HIP, AND ANKLE REPLACEMENT DEVICES

A recent surge of lawsuits from all 50 states indicate that patients are suffering ongoing injury from Exactech replacement devices. Exactech's defective medical implants have caused countless complications and ill effects in recipients of necessary hip, ankle and knee replacement devices. As in the case of Camp Lejeune, large numbers of affected individuals have sued Exactech for the cost and pain of their complications. These Exactech lawsuits seek to rectify the patient injuries that has resulted from too late a recall. If these faulty devices had been properly inspected, patient complications and lawsuits could have been avoided. Struggling with expensive, painful revision surgeries and immobilizing medical issues, numerous patients are now seeking out legal representation for their case from personal injury firms like Wettermark Keith to obtain justice through recall lawsuits.

IS A LAWSUIT AGAINST EXACTECH NECESSARY? DID MEDICAL PROVIDERS KNOW THE RISKS OF EXACTECH DEVICES?

Replacing a body part always comes with a certain level of risk. However, in the case of Exactech replacement devices, the immense health risks and high rate of revision surgery due to premature degradation of faulty components warrants lawsuits. Aggressive litigation is necessary in situations where a patient suffers injury due to negligence. In 2017, the FDA began receiving reports of faulty Exactech knee implants. The Exactech replacement devices had previously passed FDA inspection, but had done so through their accelerated 501k clearance program, believing their products to be safe and without fault. This, unfortunately, was not the case. In 2020, a study found issues with the GXL liners in Exactech hip implants, and warned the company of these issues. Exactech waited more than a year to share this information with medical professionals.

Medical professionals had no idea the replacement devices they were inserting into patients had any issues. Prior to the current recall, Exactech sent out a letter to hospitals instructing surgeons to immediately stop using their implants in all knee and ankle replacement surgeries, and to return their existing inventory of recalled devices for replacement. The recall letter instructs patients who have already received an Exactech replacement device to consult with their doctors and closely monitor symptoms. Exactech had a responsibility to patients. Their failure to use proper packing procedures warrants these lawsuits.

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WHAT'S NEXT FOR EXACTECH LAWSUITS?

More news has recently emerged regarding the Exactech lawsuit. In August 2022, Exactech expanded its recall of medical replacement devices, contacting medical providers to inform them of the recall of an additional 40,000 device components. This includes acetabular hip liners in Exactech’s Connexion, Novation, and other implant systems. Around the same time, Exactech lawyers filed a motion with the JPML requesting the formation of a new Exactech class action lawsuit. This has not yet been granted. Litigation against Exactech is ongoing, and will now be consolidated into multidistrict litigation. In simple terms, patient lawsuits may end up in national law, consolidated in front of a single judge. Exactech lawyers believe that the case will likely be settled and victims compensated before a trial is necessary.

Frequently Asked Questions

Where Are Exactech Products Made?

Exactech is headquartered in Gainesville, Florida. While it primarily targets a U.S. market, the company has a strong presence in European, Latin American, Pacific and Asian markets.The company develops and produces a wide range of medical devices, including orthopedic implants, surgical instruments, and smart technologies for use in hospitals.

What Specific Exactech Hip, Ankle, and Knee Implants are Being Recalled?

According to the FDA, Exactech has recalled certain models of Optetrak, Optetrak Logic PS, and Truliant knee inserts, components of Vantage ankle devices, and hip implant devices with Connexion GXL liners. Recently, the company expanded this recall to 40,000 acetabular hip liner components in their Connexion and Novation implant systems.

Is There a Class Action Lawsuit against Exactech?

Not yet, but there is high likelihood of one in the near future. After Exactech expanded the scope of their current recall in August 2022, the JPML renewed their consideration of consolidating all Exactech implant recall lawsuits in federal court into a new multidistrict litigation. Exactech lawyers expect a ruling within the month.

What is my Exactech case worth?

It is difficult to pinpoint, as the recall litigation has only just begun. Based on average compensation settlements in other personal injury cases concerning similar injuries, we estimate that the settlement value of a successful Exactech knee implant lawsuit is between $70,000 and $150,000, an ankle implant lawsuit between $90,000 and $175,000, and a hip implant lawsuit between $250,000 and $300,000.

How do I know if I have an Exactech case?

If you received an Exactech knee, ankle or hip implant after 2004, you may have a case. If you have suffered health consequences from the device, or have needed a revision surgery, the strength of your claim increases. Individuals who have Exactech implants (subject to the recall) that have not yet failed may still be entitled to compensation, and should file a claim.

WHAT'S NEXT FOR EXACTECH LAWSUITS?

IF YOU HAVE BEEN AFFECTED BY AN EXACTECH REPLACEMENT DEVICE, CALL WETTERMARK KEITH NOW.

If you believe you have received a defective Exactech implant and suffered negative health effects or a revision surgery to remove the device, you may be entitled to compensation. You are eligible to file an Exactech hip, ankle, or knee replacement lawsuit if you or your loved one have had an Exactech hip, knee, or ankle replacement, have suffered side effects from the device, or have required revision surgery. Legal representation is vital for your success and peace of mind. If we can help you, call (877) 715-9300 for a free consultation to discuss your case with a professional. You deserve better, and we are prepared to fight for your compensation and recovery.

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