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Jonathan Rosenfeld
J.D

March 2, 2023

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ExacTech, a medical device company producing implants and surgical devices, has recalled some replacement systems due to premature wear and tear. The system has been linked to corrosion and metal debris in the joint, which can cause pain and complications.

Patients who have had problems with their knee and ankle replacements should consult their doctor immediately to discuss options. There may be potential risks associated with the ExacTech ankle or knee device.

Are you experiencing pain after your ankle, hip, or knee revision surgery? The personal injury attorneys at Rosenfeld Injury Lawyers, LLC, are legal advocates for patients hurt by ExacTech implant systems and their defective medical devices.

An ExacTech recall lawyer from our law firm will know how to get you the financial compensation you deserve.

Call our defective medical device lawyers at (888) 424-5757 (toll-free phone number) or use the contact form today for immediate legal advice and schedule a free consultation related to your ExacTech lawsuit.

All confidential or sensitive information you share with our legal team remains private through an attorney-client relationship.

exactech recall lawsuit attorney

ExacTech Hip, Knee, and Ankle Medical Device Manufacturers

ExacTech is a medical device company that manufactures artificial hips, knees, and other orthopedic implants. The company also makes ankle arthroplasty polyethylene inserts used in knee replacements.

The ExacTech knee replacement system is utilized in knee surgical procedures, referred to as total knee arthroplasty (TKA). A complete knee replacement system is a device implanted to replace a damaged knee joint, where a TKA knee replacement surgery is generally used to treat chronic pain associated with arthritis, wear and tear, or injury.

TKAs are also used to correct knee trauma and deformities. ExacTech has several lines of knee replacement implant systems covered by the recall.

Early in 2022, the company issued a medical device correction [1] that expanded the previous recall of their OPTETRAK Comprehensive Knee System (the OPTETRAK knee implant system). The recall includes all ankle and knee arthroplasty polyethylene inserts packaged in non-conforming vacuum bags.

exactech recall lawsuit lawyers

Hazardous Packaging

ExacTech said the recall was because the packaging was not per the required specifications. The vacuum bags utilized were oxygen-resistant but lacked the necessary secondary protective mechanism — a barrier layer made of ethylene-vinyl alcohol. Plastic items may degrade prematurely due to oxygen exposure, a chemical reaction known as oxidation.

Polyethylene inserts that are damaged may wear out sooner and cause problems with the implants. The defect could injure the patients and make revision surgery necessary.

The US Food and Drug Administration [2] classifies the recalled ExacTech knee replacement implant systems as a Class II recall. Using the recalled Optetrak knee implants may cause temporary or medically reversible adverse health consequences.

If you or a loved one has had artificial knee, ankle, or hip implant surgery since 2010 and experienced complications, you may be eligible to file an ExacTech recall lawsuit. You may be able to recover compensation for your injuries, medical bills, and other damages.

What Is Knee Replacement Surgery?

In this surgery, also called knee arthroplasty, the surgeon will remove the damaged parts of your knee joint and replace them with an artificial joint.

The main goal is to relieve pain and improve joint function. The surgery is usually performed under general anesthesia. It takes about two to four hours, but most people have to stay in the hospital for three to five days after surgery.

However, any ankle or knee replacement procedure that goes wrong due to medical malpractice or a defective knee replacement unit, such as the ExacTech knee replacement insert or total ankle replacement, will likely require revision surgery.

A revision surgery helps relieve pain but also has a higher risk of complications. Moreover, revision surgeries to fix ExacTech knee implants lead to added medical expenses.

What Is a Knee Replacement Device?

A knee replacement device, a prosthesis, is a surgically implanted prosthetic. It replaces the weight-bearing surfaces of the knee joint to relieve pain and disability.

Doctors choose this option when other treatments, such as physical therapy, medication, and weight loss, have failed to provide relief.

Knee replacement involves replacing the damaged or worn-out surfaces of the knee with artificial parts, called implants. The three main types of devices are:

  • Total Knee Replacement (TKR): [3] In this procedure, doctors replace both the shinbone (tibia) and kneecap (patella) with metal implants. Surgeons place a plastic spacer between these two new metal surfaces to create a smooth gliding surface.
  • Partial Knee Replacement (PKR): In this procedure, doctors only replace the damaged portion of the knee with a metal implant. The healthy bone and cartilage are left intact.
  • Unicondylar Knee Replacement (UKR): It is also known as a partial knee replacement. In this procedure, only the damaged compartment of the knee is replaced. However, the incision is smaller than that of a TKR.

The ExacTech replacement implant is an example of a knee replacement device made of metal and plastic. It is a total knee replacement unit used in knee surgery for patients with arthritis or other conditions that cause damage to the knee joint.

The recent ExacTech recall lawsuits were filed due to the defective nature of some ExacTech knee replacement systems. As a result, many patients had to undergo corrective revision surgery to fix the damage caused by an ExacTech knee or ankle replacement implant system.

In an ExacTech knee implant lawsuit, the patient can seek compensation for the economic and non-economic damages caused by the ExacTech knee, ankle, or hip implant. The same applies to ankle replacement surgeries involving ExacTech replacement systems.

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Recalled Hip Replacement Units

Besides knee and ankle implants, ExacTech has also recalled many hip replacement units. The ExacTech Connect GXL liners are used with the company’s G2 metal-on-metal hip prosthesis and have been linked to severe complications.

The FDA has received reports of metallosis, tissue damage, and device failure in patients who have received these defective hip implants. This recalled ExacTech hip replacement unit is used in the following medical devices:

  • ExacTech Acumatch®
  • ExacTech MCS®
  • ExacTech Novation®

ExacTech has asked hospitals to return these hip replacement devices to the company and not use them in any hip replacement procedures due to implant failure. People who already have these ExacTech hip replacement units in their bodies may undergo corrective surgery to remove and replace the device.

A revision can be a painful and complicated surgery with a long recovery time. If you or a loved one has received an ExacTech hip replacement unit, you should contact a lawyer to discuss your legal options and see if your case is eligible for one of the ExacTech recall lawsuits filed against the company.

You might be able to file an ExacTech hip replacement lawsuit, claiming compensation for medical expenses and other losses caused due to the company’s hip replacement devices. Until now, many patients have filed ExacTech recall lawsuits against the company.

What Problems Are Associated with the Recalled ExacTech Implant Devices?

To understand how an implant can become defective, it’s essential to know how these implants are made. An average knee insert has these parts:

Femoral Component

The femoral component is the part that goes into your thigh bone or upper leg. It’s made of metal alloys, plastics, and ceramics.

Tibial Tray Component

The tibial tray component is the part that goes into your shinbone or lower leg. Like the femoral component, the tibial insert comprises different metals, plastics, and ceramics.

Patellar Button Component

The patellar button component is the part that goes into your kneecap or patella [4]. In most cases, this component is made of metal alloys or plastics.

Polyethylene Insert Component

The polyethylene component is a plastic insert between the tibial tray [5] and the femoral component. It cushions the knee joint.

When a knee or ankle replacement unit is inserted, the surgeon first makes an incision in your leg to reach the bones that need replacement.

Once they access your bones, they remove any damaged cartilage and bone. Next, they’ll shape the bones to fit the latest components. Finally, once the bones are ready, they’ll insert the new parts and secure them with either screws or cement.

After that, they’ll close up the incision with stitches or staples. In some cases, they may use a drain to prevent fluid buildup.

Recalled Knee and Ankle Replacement Problems

The affected ExacTech knee and ankle replacements were not made according to the design specifications. In addition, the incorrect packaging led to vacuum sealing defects. As a result, the devices may not have undergone adequate sterilization.

In particular, the knee or ankle implant could get damaged during transport and cause serious patient injuries. Such ankle implants using ExacTech recall materials could cause:

  • Infection
  • Nerve damage
  • Loosening of the device
  • Bone fractures
  • Need for revision surgery

Patients may undergo revision surgery to replace or repair a failed joint replacement using an ExacTech recall device. Since ExacTech knee and ankle prosthetic units can cause serious problems; affectees can file an ExacTech recall lawsuit.

exactech recall lawsuit attorney

Symptoms of a Defective Knee or Ankle Implant Systems

People with defective ankle, knee, or hip implant systems will experience specific symptoms that could mandate corrective revision surgery. After the ExacTech recall, your surgeon will likely contact you. However, you shouldn’t wait to hear from them if you already have the following symptoms:

Ankle Swelling

Doctors usually place joint replacements in areas with a lot of fluid. Your body’s natural reaction to the presence of a foreign object is to try and flush it out with extra fluid. It can cause significant ankle swelling, which may or may not be accompanied by pain.

Pain

Most patients with recalled ExacTech implants experience pain in the joint area, although it isn’t always the case. The pain can range from a dull ache to sharp and debilitating [6]. It may be constant or intermittent and get worse with activity.

Instability

Do you feel like your ankle or knee is “giving out” on you? A loosening of the implant often causes such a feeling. If you have this symptom, you should see your doctor right away.

As an implant loosens, it becomes completely detached from the bone. As a result, it can lead to instability, pain, and swelling.

Inability to Bear Weight

Joint replacement surgeries allow patients to bear weight on the affected joint again. However, if your knee or ankle is defective, you may find it difficult to put any weight on it.

Grinding Noise

A defective ExacTech medical device in your knee or ankle may make a grinding noise when you move it. The noise is usually a sign that the implant is loose.

See your doctor immediately if you have any of these symptoms. You may need to have your ankle or knee replacement system replaced. In most cases, the solution is corrective surgery [7].

The Real Price of Faulty Joint Replacements

ExacTech is providing refunds for direct costs incurred in connection with the recall. They have contracted with Broadspire, a Third Party Administrator, to handle claims. Although ExacTech’s gesture may appear helpful, the reimbursement program will probably not be enough to fully compensate the victims for their losses.

Surgical Risks

Elderly patients who need knee and ankle replacements are typical. Age-related health issues could make revision surgery impossible. These patients might be compelled to deal with the persistent pain and limited mobility that the initial replacement was intended to treat.

Despite the health hazards, some people may decide to have surgery. Premature death or other serious problems could result.

Secondary Health Complications

In destroying bone tissue, osteolysis presents the following additional risks:

  • The damaged bones are shattering
  • Falls that result in severe harm like brain damage and extra fractured bones
  • Reduced mobility, which puts the patient’s independence in jeopardy
  • Depression and loneliness

Unnecessary Distress and Suffering

Revision arthroplasty recovery [8] is a complicated, painful procedure that patients are unnecessarily forced to undergo when defective medical devices cause harm. The quality of life is drastically diminished for people unable to have revision surgery.

Successful knee, ankle, and hip replacements give patients independence and pain relief. Patients lose hope when these benefits are lost due to a manufacturer’s irresponsibility. As a result, health deteriorates. Financial stress is added as personal care, and health care needs rise due to worsening health and decreased freedom.

Knee replacements are common in the elderly with arthritis or similar conditions. Likewise, hip replacements are required due to age or severe falls.

Are you or a loved one victims of a defective knee, ankle, or hip implant replacement device? You can take legal action by filing an ExacTech lawsuit to ensure you get compensated for your losses.

Whether you’ve had a total knee replacement or partial joint procedure, ask your doctor if they used ExacTech ankle, knee, or hip ankle replacement implants. If they used a recalled device in your surgery and you experienced side effects, you could file an ExacTech lawsuit.

Not many personal injury cases have been filed against ExacTech for the recalled devices used in ankle, knee, and hip replacements. Thus, there’s no class action ExacTech lawsuit at the moment. On top of that, not enough new claims are filed because most patients are unaware of the recall.

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ExacTech Lawsuit FAQs

Our personal injury law firm understands that many families have unanswered questions concerning defective hip, ankle, or knee replacements and who is responsible for damages, including paying for corrective revision surgery.

Our law firm’s experienced product liability attorneys have answered some of these questions below. Contact us at (888) 424-5757 for additional information or to schedule a free consultation.

What Is an ExacTech Lawsuit?

An ExacTech lawsuit is a legal action against the company for injuries related to their recalled joint replacement devices. The products in question were intended to allow patients to gain mobility with little pain and discomfort but instead caused many of them to suffer from complications, including:

  • Infections
  • Fractures
  • Joint loosening
  • Dislocation
  • Metal poisoning due to metal-on-metal wear

Injured victims are filing ExacTech lawsuits for their damages such as medical costs, lost wages, and pain and suffering caused by the faulty devices. Each recall lawsuit can provide compensation from the manufacturer based on strict liability or negligence theories.

In a case involving strict liability, the victim would not have to prove wrongdoing on the part of ExacTech—only that they used a defective product and suffered harm as a result.

Injured victims must understand their rights to file a successful ExacTech lawsuit. A qualified attorney specializing in product liability cases will be better equipped to handle these complaints as they understand the complexities of defective product cases, industry best practices, and relevant case precedents.

What Should a Patient with a Recalled ExacTech Ankle, Knee, or Hip Implant Do?

The manufacturer told surgeons not to insert a recalled ExacTech implant joint replacement unit in any patient. Any hospitals or surgeons possessing the recalled implants should return them to ExacTech.

If you had, or are scheduled to have, surgery to insert an ExacTech ankle prosthetic unit, you should speak with your surgeon about the ExacTech recall. You may also want to consider seeking a second opinion from another surgeon about ExacTech implants.

If you already had surgery to insert an ExacTech implant, your doctor should monitor you for any signs of insert failure. ExacTech has advised doctors to monitor patients and look for the following symptoms:

  • Pain
  • Swelling or grinding joint noise
  • Inability to bear weight
  • Instability of the ankle or knee

If the doctor suspects a failed device, they should order an MRI or X-Ray to check for metal corrosion. If the device is confirmed to have failed, you will likely need corrective revision surgery to remove and replace the implant.

Legal Options for Defective Hip Replacements

It is vital to note that not all patients who have received a recalled device will experience problems. However, if you are experiencing any of the above symptoms due to knee implant failure, you should talk to your healthcare provider.

If you do not have any of these symptoms, there’s no need for preemptive surgery to remove the medical device [9]. Only people with defective ExacTech implants should be scheduled for surgery, especially if they experience a lack of mobility and pain.

Following your doctor’s confirmation that you have a recalled device and that it is causing you health problems or might result in problems in the future, you should consider calling one of our experienced attorneys. They will be able to present your legal options regarding the existing ExacTech lawsuits and their outcomes to make the best decision for your situation.

Who Can File an ExacTech Knee Replacement Lawsuit?

You can file an ExacTech recall lawsuit if you or a loved one had an ExacTech knee implant with defective packaging and the insertion caused severe side effects or required revision surgery.

The ExacTech knee replacement lawsuit would seek compensation for your medical expenses, lost wages, and pain and suffering.

If you have already had revision surgery to remove the ExacTech implant, you may still be able to file an ExacTech recall lawsuit seeking compensation for your costs.

You may also join an existing ExacTech class-action lawsuit or MDL (multidistrict litigation) against the manufacturer.

Which Knee, Ankle, and Hip Replacement Devices Are Part of The Exactech Implant Recall Lawsuits?

ExacTech products [10] could be used in knee, hip, or ankle surgery. However, the company has recalled some products due to non-compliant packaging. The following devices are a part of the ExacTech recall:

  • Optetrak® All-polyethylene CR Tibial Components
  • Optetrak® All-polyethylene PS Tibial Components
  • Optetrak® CR Tibial Inserts
  • Optetrak® CR Slope Tibial Inserts
  • Optetrak Logic® CRC Tibial Inserts
  • Optetrak Logic® PS Tibial Inserts
  • Optetrak Logic® PSC Tibial Inserts
  • Optetrak Logic® CC Tibial Inserts
  • Optetrak® PS Tibial Inserts
  • Optetrak® HI-FLEX® PS Tibial Inserts
  • Optetrak Logic® CR Tibial Inserts
  • Optetrak Logic® CR Slope Tibial Inserts
  • Truliant® CRC Tibial Inserts
  • Truliant® PS Tibial Inserts
  • Truliant® PSC Tibial Inserts
  • Truliant® CR Tibial Inserts
  • Truliant® CR Slope Tibial Inserts
  • Vantage® Fixed-Bearing Liner Component

Nearly 60,000 OPTETRAK® and OPTETRAK Logic® units have been implanted in patients since 2014. Meanwhile, 25,000 TRULIANT® units have been inserted in patients needing knee and ankle replacement surgery.

If you are unsure or cannot remember exactly which insert was used in your knee replacement procedure. You should talk to your physician or surgeon about your personal case file from where you had the surgery. They will have this critical information in your medical records.

What Compensation Can Victims of Defective ExacTech Knee and Ankle Replacements Receive?

Defective hip, ankle, and knee replacement devices can lead to severe injuries and complications. You may be eligible for compensation if you or a loved one has been affected by a defective ExacTech knee, ankle, or hip replacement unit.

Whether you participate in an existing ExacTech class-action lawsuit, multidistrict litigation (MDL) or an individual one, you and your loved one can be compensated for:

Medical Costs

Premature wear of the ankle arthroplasty polyethylene inserts can lead to the need for revision surgery. It can be costly, and victims may face mounting medical bills.

In such a case, you can receive compensation for out-of-pocket expenses related to your injury, including:

  • Medical costs
  • Physical therapy
  • Assistive devices

Pain and Suffering

You may also be eligible for pain and suffering damages. These are non-economic damages intended to compensate you for your physical pain and emotional suffering.

In some cases, victims of defective knee replacements may also be able to recover punitive damages.

Punitive Damages

Jurors award punitive damages in cases where the at-fault party acted with gross negligence or malice. Punitive damages are intended to punish the at-fault party and deter similar behavior in the future.

An experienced attorney can help you understand your legal rights and options. If you received a recalled ExacTech device for a total hip replacement or total joint replacement, you need to talk to your doctor immediately.

Recalled ExacTech Knee, Hip, and Ankle Implants Causing Severe Side Effects

ExacTech provided orthopedic surgeons with monitoring guidelines for the recalled devices. A failed implant can cause several problems, such as bone loss and loosening joints.

Besides bone loss, defective medical devices from ExacTech can also lower your range of mobility and cause excruciating pain in the thigh bone and hip regions, especially in cases of total joint replacement.

Many recalled ExacTech systems are causing side effects. If you have been affected, consult your doctors and personal injury lawyers to get all the information you need to participate in the ExacTech implant recall lawsuits.

Is There an ExacTech Class Action Lawsuit or MDL?

ExacTech, a company that manufactures joint medical device replacements, has faced numerous recall events in recent years. Many hip, knee, and ankle replacement devices have been subject to recalls due to potential complications or adverse effects.

Many of the patients affected have been left with debilitating pain and other health problems due to these recalled products.

No class action lawsuit against Exactech regarding the recalled joint replacement devices was filed. Individual victims who have suffered harm after receiving an Exactech device are pursuing several personal injury lawsuits.

Eastern District of New York Consolidated ExacTech Lawsuits

The US Judicial Panel on Multidistrict Litigation (JPML) [11] has been considering consolidating some of these individual cases into multidistrict litigation, or MDL. The JPML has assigned Eastern District of New York Judge Nicolas Garaufis to consolidate about 33% of the current ExacTech lawsuits.

The MDL consolidation would allow for all of the cases to be tried before one judge in the same court and could increase the efficiency and speed at which compensation is obtained

While each case will involve various factors, such as the severity of the injury and the number of damages sought, many victims are battling for their rightful compensation for medical costs and other losses related to their ordeal.

Hire a Product Liability Lawyer to Resolve Your Defective Medical Implant Compensation Claim and File Your ExacTech Lawsuit

Are you suffering from a defective ExacTech implant? Many patients are filing ExacTech knee and ankle lawsuits seeking financial compensation for damages caused by the replacement device manufacturer.

Call the personal injury attorneys at Rosenfeld Injury Lawyers, LLC at (888) 424-5757, or use the contact form to schedule a free consultation to discuss your claim. ​​Our experienced personal injury lawyers have a long, successful track record of standing up to large companies like ExacTech.

We can assist you in determining the actual cost of your losses so that you can receive compensation that satisfies your needs and is fair compensation for the harm you have endured.

We accept every hip, ankle, and knee replacement lawsuit through a contingency fee agreement. This arrangement ensures you pay nothing until we resolve your ExacTech lawsuit through a negotiated settlement or jury verdict.

Resources: [1] ExacTech, [2] FDA, [3] Illinois Bone and Joint Institute, [4] NIH, [5] Clinical Orthopaedics and Related Research , [6] St. Vincent Charity Medical Center, [7] PubMed, [8] PubMed, [9] ClinicalTrials.gov, [10] ExacTech, [11] US Judicial Panel on Multidistrict Litigation

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