What is the Exactech Lawsuit?

The U.S. Food and Drug Administration (FDA) announced recalls in August 2021 on Exactech knee, hip, and ankle replacements that contained polyethylene parts.

Packaging errors on joint replacement devices have been found to cause the oxidation of polyethylene parts.

This is a cause for concern because oxidation can degrade polyethylene inserts over time, leading to the potential need for revision surgery.

Implants dating back as early as 2004 are included in the Exactech recall.

Due to the sheer amount of implants included in the Exactech recall, coupled with the dangers these recalled devices may pose, lawsuits have been filed against Exactech across the United States.

Packaging errors on the device have been found to cause the oxidation of polyethylene parts:

• Oxidation can degrade polyethylene inserts over time, leading to the potential need for revision surgery.
• Exactech said that the degradation and premature wear of polyethylene inserts cause a “statistically significant” rate of failure in their implants.

Exactech Lawsuit Injuries

Exactech implants have been linked to various injuries and complications due to faulty packaging and defects in polyethylene parts.

Patients who received these defective implants may suffer from:

• Accelerated debris
• Bone loss from osteolysis
• Limited mobility or pain while walking
• Inability to bear weight
• Cracking, grinding, clicking, or other noises in the joint
• Joint swelling
• Instability
• Polyethylene wear
• Revision surgery because of osteolysis or polyethylene wear

These injuries can be debilitating and may require corrective revision surgeries, causing significant pain and disruption in the lives of affected individuals.

About Exactech (Company Background)

Exactech is a global medical device company located in Gainesville, Florida.

Founded in 1985, Exactech produces medical implants, instruments, and technologies related to joint replacements and joint replacement surgeries to be sold to physicians and doctors.

What Exactech Products Are Recalled?

According to the Exactech recall notice, the recalled products include various lines of ankle, hip, and knee implant components.

Recalled knee and ankle replacement product lines include:

• Optetrak;
• Optetrak Logic;
• Truliant;
• Vantage.

Recalled hip replacement products include liners from:

• Acumatch;
• MCS;
• Novation.

How Do I Know If I Have A Recalled Exactech Implant?

Many patients do not know how the implant used for their knee replacement, ankle replacement, or hip replacement was produced.

Many patients also don’t know whether the implant had a potentially faulty insert or was sealed in defective packaging.

We suggest asking your doctor or orthopedic surgeon for an updated copy of your medical records to determine the implant type and serial number.

From there, you can check the Exactech recall website to cross-reference your information with their recall documents.

Exactech Lawsuit Settlement Amounts

If you or a loved one has been affected by complications from an Exactech implant, you might be wondering about the potential for financial compensation through a settlement.

While the Exactech Lawsuit is still in its early stages, it’s essential to understand the factors that could influence the average settlement amount.

As of now, there is no concrete data on the average Exactech settlement since the legal process is ongoing.

However, our team of experienced Exactech Lawyers has been closely monitoring similar cases and can provide estimations based on historical data.

The average Exactech settlement is projected to fall within the range of $50,000 to $300,000.

The actual amount can vary significantly depending on several critical factors:

1. Individual Case Details: The specifics of your case will play a crucial role in determining the potential settlement. Factors such as the severity of the complications, the extent of damages, and the impact on your quality of life will be taken into account.

2. Medical Expenses: The costs associated with corrective surgeries, ongoing medical treatments, and rehabilitation will be carefully evaluated when calculating the settlement amount.

3. Lost Wages and Future Earnings: If the complications from the Exactech implant affected your ability to work, resulting in lost wages or diminished future earning capacity, these financial losses will be considered during the settlement negotiations.

4. Pain and Suffering: The physical and emotional distress caused by the implant’s failure and subsequent complications will be factored into the settlement equation.

5. Legal Representation: Having a skilled and experienced Exactech Lawyer representing your case may impact the outcome of the settlement. A strong legal team will fight to maximize your compensation.

6. Liability Considerations: The degree of responsibility attributed to Exactech for the defective implants will also be a crucial factor in determining the settlement value.

It’s crucial to understand that while our estimations provide insight into potential settlements, there is no guarantee that your Exactech Lawsuit will result in financial compensation.

Each case is unique, and outcomes can vary based on individual circumstances and the evidence presented.

Exactech Implant Device Failure: Issues Were Known By the Manufacturer

The Exactech knee replacement system has a long history of high failure rates and problems.

The Australian Orthopaedic Association identified the recalled Exactech Optetrak Knee Implant System as having a higher-than-expected rate of failure and requirement of revision surgery.

When searching for adverse event reports and other issues on Exactech implants through the FDA Manufacturer and User Facility Device Experience (MAUDE) portal, thousands of reports on Exactech knee replacement devices, hip devices, and ankle replacements have been made since 2013 at least.

Each of the adverse event reports on the FDA MAUDE portal detail the injuries and health effects of faulty Exactech implants, with some requiring paragraphs of detail, and others simply stating the effects of the implant, such as the event reports below:

• May 18th, 2023: “Patient had to undergo revision, arthroplasty, knee on the left side, due to failed exactech knee hardware. This product has been recalled by the company.”
• May 11th, 2023: “Patient had total hip liner implant that was recalled which required revision surgery.”
• July 7th, 2022: “Patient had 2012 right total hip replacement with Exactech Connexion GXL Acetabular Liner with early wear, acetabular osteolysis leading to periprosthetic fracture requiring complex revision right total hip arthroplasty.”

These are just a few reports of injuries and revision surgery in patients with recalled Exactech implants.

Exactech Implants Received Fast-Track FDA Approval

Exactech obtained 501(k) clearance for its knee replacement systems, which is a “fast-track” approval path that does not require full testing for safety and effectiveness.

By obtaining 501(k) clearance, Exactech bypassed the rigorous FDA review and approval process, allowing their knee replacement systems to reach the market without proving their safety and effectiveness adequately.

This “substantial equivalence” pathway may have contributed to the company’s failure to identify and address the high failure rates and other problems associated with their knee implants early on.

The lack of comprehensive testing and scrutiny under this process highlights the need for stricter regulations to ensure the safety of medical devices and protect patients from potential harm.

Exactech Knew of Problems with Faulty Implants

Reports suggests that Exactech was aware of the defects in their Optetrak knee implant system even before the company was acquired by TPG Capital in 2018.

By delaying the recall until after going private, the company may have sought to avoid the negative impact on its stock value and potential shareholder lawsuits.

The alleged quiet replacement of some defective implants without public disclosure further compounds the concerns about transparency and accountability.

Court records allege that Exactech sales representatives were present during surgeries and witnessed numerous cases of premature Optetrak failures.

Surgeons and sales reps alike observed evidence of premature degradation of the plastic inserts.

Despite having a duty to report these findings to the company’s engineering and medical departments, Exactech’s sales reps failed to initiate necessary investigations or alert surgeons, patients, or the FDA about the implant’s high failure rate.

This lack of action and transparency raises concerns about ethical practices and the responsibility of medical device manufacturers to prioritize patient safety.

Exactech Previously Reprimanded by US Department of Justice in 2010

Exactech’s controversies don’t lie just within its faulty joint replacements.

The company was forced to pay a settlement agreement by the US Department of Justice (on behalf of the Office of the Inspector General of the Department of Health and Human Services) in 2010.

The civil settlement agreement published by the DOJ states that:

“Exactech used, and conspired to use, various forms of financial agreements to induce orthopaedic surgeons to cause providers to use Exactech’s hip and knee joint replacement implants in order to maintain and increase Exactech’s market share.

These financial agreements included, but were not limited to fee-for-service contracts, fixed fee contracts, and product development contracts, among others.

The United States contends that certain of these financial agreements were improper, that the remuneration paid thereunder was improper and/or unlawful, and that these arrangements caused hospitals and physicians to submit false and fradulent claims for replacement of hip and knee joints using Exactech implants to Medicare.”

Exactech Ankle And Knee Implant Recall

The Exactech ankle and knee recalls cover implants dating back to as early as 2004.

Recalled ankle replacement implant system and knee replacement implant systems include:

• Optetrak (released in 1994);
• Optetrak Logic (released in 2009);
• Truliant (released in 2017);
• Vantage (released in 2016).

Contact your doctor or orthopedic surgeon for your detailed medical records to verify whether or not the implant you or your loved one received was on the recall list.

You can also use the Exactech serial number look-up page by accessing the implant’s serial number and typing it into the Exactech database.

Potential Injuries From Recalled Exactech Ankle and Knee Implants

As mentioned above, Exactech ankle and knee implants are recalled due to faulty packaging and tibial inserts, thus leading to further implant complications.

Injuries or symptoms related to faulty joint replacements can range from minor to serious, typically progressing in severity over time.

While people with defective ankle or knee implants may feel the most pain in the affected joint(s), they may also experience pain, swelling, and instability in other joints, as well.

Patients with faulty knee implants could experience other complications apart from pain and fatigue.

Injuries from faulty Exactech devices include, but are not limited to conditions such as:

• Arthritis;
• Osteoarthritis;
• Osteolysis (bone degeneration);
• Synovitis.

Additional injuries or symptoms associated with faulty knee implant devices include:

• Pain and swelling near implants and joints;
• Extreme discomfort;
• Grinding, clicking, and other foreign noises near an affected joint;
• Difficulty when walking, standing up, or lying down;
• Instability and soreness.

Joint pain can be debilitating and can affect the rest of your body.

Remember to speak to a medical professional as soon as possible if you’re experiencing joint pain from an Exactech implant.

What Health Problems Are Linked To Faulty Exactech Knee Implants?

Defective Exactech knee and ankle implants, which can degrade and give way, may also lead to various health conditions and adverse health effects.

A correlation between synovitis and polyethylene joint replacements has been found by researchers.

Synovium is the thin membrane lining around joints.

Synovitis, simply put, is tissue inflammation that can cause severe pain in areas around joints and can lead to permanent damage if left untreated.

Individuals with a faulty knee replacement may also experience osteolysis, a painful medical condition that degrades bone tissue.

Prolong pain after knee replacement surgery is not normal.

Contact your doctor if you experience new or worsening pain near your implanted device.

Exactech Hip Implant Recalls

A hip replacement is made up of a couple of main components that work together to stabilize the hip including the stem, hip cup, and liner.

Hip replacement liners are typically made of plastics like polyethylene.

Because of constant friction, liners tend to wear down over time.

In the case of the Exactech hip recall, liners have been found to be prematurely weakened because of packaging defects.

The Exactech recall covers implant products dating back to as early as 2004.

Recalled Exactech hip implant liners include:

• MCS;
• Acumatch;
• Novation;
• Connexion GXL.

To find out if your hip replacement liner is included in the recall, contact your doctor or orthopedic surgeon for detailed medical records.

Potential Injuries From Recalled Exactech Hip Replacement Devices

Defective packaging errors have been found to cause oxidation of polyethylene tibial inserts.

Oxidation of these polyethylene inserts can lead to their degradation in the body, potentially exposing patients to numerous adverse health effects and signaling the need for corrective revision surgery.

Additionally, individuals may experience similar symptoms related to other recalled Exactech implants like:

• Arthritis
• Synovitis
• Osteolysis.

Injuries or symptoms related to defective hip replacement liners can be minor or extremely serious, and these injuries typically progress in severity over time.

Some patients with defective Exactech hip liners may feel the most pain in their hip and midsection.

They may also experience pain, swelling, and instability in other joints that retain pressure from the altered posture.

Patients with defective hip liners could experience other complications apart from pain and fatigue, including:

• Pain and swelling on hips or midsection;
• Extreme discomfort around hips and other body parts and joints (back, knees, ankles, shoulders);
• Feelings or sounds of grinding or clicking in hips;
• Difficulty walking, standing up, or lying down;
• Instability, soreness and posture change that result in further pain;
• Possibility of infection.

While it isn’t ideal, those experiencing these symptoms may have to undergo corrective surgery to repair what the recalled implant has done.

Be sure to contact your doctor or orthopedic surgeon to see what steps you should take when experiencing pain from a hip implant.

What is the Exactech MDL?

As Exactech Lawsuits are being filed across the country, the Judicial Panel on Multidistrict Litigation (JPML) has consolidated these lawsuits in the US District Court for the Eastern District of New York.

Multidistrict litigaiton (MDL) is a special federal legal procedure designed to speed up mass tort lawsuits.

When a large number of people have all been affected by the same product, the federal court system allows for the cases to be consolidated into a single district court for consistency of decision making and pretrial discovery.

Is There an Exactech Class Action Lawsuit?

No, there is not a class action lawsuit for injuries associated with recalled Exactech implants.

These lawsuits are consolidated into multidistrict litigation (MDL).

Class action lawsuits are different from MDL.

In the case of a settlement in a class action lawsuit, the compensation is divided evenly among all plaintiffs regardless of the individual circumstances of each person.

In multidistrict litigation, however, a settlement would be distributed to plaintiffs according to the facts, damages, and individual circumstances of each person.

Do I Qualify For An Exactech Lawsuit?

Patients who received a recalled Exactech implant or replacement and subsequently suffered injuries related to polyethylene degradation may qualify for a lawsuit.

Those who received the implant but have not yet experienced symptoms should contact a medical professional for more information, and later contact an attorney if injuries are discovered.

You may be eligible to file a legal claim if you have an Exactech knee, ankle, or hip implant, or have suffered injuries related to a failed implant or its related defects.

Additionally, Exactech is in the process of distributing letters to surgeons on the recalls as more information is coming out.

Surgeons are then expected to dutifully inform their patients who have received Exactech Implants of the associated dangers.

If you are unsure whether you qualify for an Exactech Recall Lawsuit, contact TorHoerman Law.

TorHoerman Law offers free, no-obligation case consultations for all potential clients.

Can I File A Lawsuit Against Exacatech If I Don’t Receive A Letter?

Yes, you can file an Exactech Recall Lawsuit if you do not receive a letter.

Exactech’s recall letter is not issued to consumers or manufacturers.

Instead, individual surgeons have a responsibility to inform those affected by the Exactech recall.

Generally speaking, people who have relocated or lost contact with a physician should continue to receive updates from their former medical professional.

If a doctor resigns from their position at a hospital, Exactech could fail to notify affected patients they have served.

How To File An Exactech Lawsuit

The civil litigation process is very time-consuming and requires keen attention to detail as well as extensive knowledge of legal jargon.

It can be overwhelming for those who are already coping new or worsening pain and the complications and trauma from their injuries.

With the help of an experienced Exactech Lawyer, you should begin gathering evidence that will support your claim in court.

Your legal representation will help you gather evidence and assess damages related to your situation.

Hiring An Exactech Lawyer

As we mentioned, hiring a lawyer with extensive knowledge of the Exactech implant recalls will be extremely helpful for your case.

Your Exactech Lawyer will be able to simplify the legal process and work with you to strengthen your claim.

Hiring an attorney with a track record of success, who has your best interest in mind, and is adept in handling an attorney-client relationship is key in ensuring a strong case and claim for compensation.

In the event that you or a loved one suffered injuries because of a faulty Exactech knee, ankle, or hip replacement, contact an attorney as soon as possible.

TorHoerman Law’s team of expert personal injury attorneys specialize in faulty medical device litigation.

The road to recovery from personal injuries is tough, but you do not have to go through it alone. Contact us today to find out your legal options and how we can help you!

Gathering Evidence for Exactech Lawsuits

Gathering evidence is a crucial step in building a strong case.

Evidence to gather includes any documentation or records pertaining to your injuries and your defective medical devices.

Evidence in an Exactech Lawsuit may include:

• Medical records
• Doctor’s notes
• Witness testimony
• Photos and videos
• Employment records
• Any other evidence proving use of Exactech implants and subsequent injury

Contact an attorney who is experienced in personal injury cases to gain personalized insight as to what evidence should be collected in order to build a strong case.

Assessing Damages

Damages are the total amount of losses related to injuries suffered from a recalled Exactech knee replacement, hip implant, or other joint implants.

An experienced attorney and their law firm will help you assess your damages.

Damages in Exactech Lawsuits may include:

• Medical bills
• Future medical expenses
• Lost wages or earning ability
• Permanent disability
• Lost quality of life
• Pain and suffering
• Emotional damages
• Other compensatory and punitive damages

Assessing these damages is important because it helps your lawyer get a better understanding of the way the Exactech implant impacted you and what length of compensation you qualify for.

Mitigating Injuries

Mitigation is another critical element of any personal injury claim.

This step involves attempting to lessen the impact of injuries and costs associated with a recalled Exactech implant.

Proper steps to mitigation for an Exactech Lawsuit include:

• Receiving an official injury diagnosis;
• Seeking medical treatment for an injury;
• Following your doctor’s orders;
• Discussing revision surgery, if your doctor says it is safe (and in your best interest);
• Doing everything in your power to minimize the extent of your injuries.

Mitigation is a very important step in building a strong, honest claim.

If you wait too long and the statute of limitations of your case expires, you may not be eligible to file a lawsuit or receive any compensation.

Contact TorHoerman Law today and let us help you take the final steps towards finally healing from the past.

TorHoerman Law - Your Exactech Lawyers

Hip, knee and ankle replacements are vital medical operations that can drastically improve somebody’s life if done correctly.

However, defective Exactech implants have been found to cause serious injury in patients.

If you or a loved one suffered injuries due to a defective Exactech implanted device, you may be eligible to file an Exactech Lawsuit and pursue financial compensation.

Contact TorHoerman Law for a free consultation.

You can also use the chatbot on this page for a free and instant case evaluation.

TorHoerman Law’s team of expert personal injury attorneys specialize in faulty medical device litigation.

We have won more than $4 billion in verdicts and negotiated settlements for our clients.

Our law firm operates on a contingency fee basis.

This means that you do not owe any amount of payment until you have been justly compensated for your losses.

The road to recovery from personal injuries is tough, but you do not have to go through it alone.

The TorHoerman Law team focuses on fostering a constructive attorney client relationship and will work hard for your case.

Contact us today to find out your legal options and how we can help you.

TorHoerman Law – the law firm you can trust for your Exactech Lawsuit