Exactech Implant Recall Lawsuit
Defective Exactech hip, knee, and ankle implants can harm your body and your peace of mind. They can lead to pain, traumatic revision surgery, and even amputation or other permanent physical disabilities. An Exactech lawsuit is a means to get justice and recover the compensation you deserve. The Lanier Law Firm has a long history of winning verdicts and settlements on behalf of injured individuals against medical device companies like Exactech.
Exactech has issued a recall dating back to 2004 for hundreds of thousands of its hip, knee, and ankle replacement components. Worse still, a pending lawsuit alleges that Exactech has known about the dangerous defect for at least 17 years.
If you received a defective Exactech implant and suffered an injury, a pharmaceutical liability lawyer at The Lanier Law Firm can help you pursue substantial compensation through a lawsuit.
Evan M. Janush: The latest update on this litigation is that the case has been progressing through discovery, and on May 10th there will be a science day taking place in Florida where it will be consolidated with the MDL and the Florida State Consolidated Litigation. And this is when the plaintiffs and the defendant come together before the court, and they address the scientific factors of the case. Essentially, it is to in inform the parties and really educate the court as to what the claimed defect is or defects are, and move on from there to address questions that the court may have.
Is there a class action lawsuit against Exactech?
The litigation against Exactech is moving forward as a multidistrict litigation, also known as MDL. While an MDL is similar to a class action, the two are not the same.
In an MDL, each case is transferred to a single state or federal court. Out of all those cases — sometimes tens of thousands — the MDL court hears a few test cases, known as bellwether cases. The results of these bellwether cases help the parties anticipate how the remaining cases will resolve and reach a fair settlement.
In federal court, the Exactech cases have been transferred to the Eastern District of New York and will be managed by Judge Nicholas G. Garaufis under MDL 3044.
Which Exactech implants have been recalled?
In the U.S., the recall includes nearly 200,000 hip, knee, and ankle replacement devices, including inserts, liners, and cups. Each of the devices includes a component made of polyethylene. According to the American Association of Hip and Knee Surgeons, these polyethylene components provide cushioning between the metallic parts of the joint replacement device and, essentially, function as cartilage.
Recalled Hip Implants
On June 29, 2021, Exactech quietly recalled the hip implant acetabular liners for its Novation-branded hip replacement systems, citing a risk of premature wear, especially along the edges. However, according to the MDL complaint, the company notified only Exactech agents, representatives, and distributors; health care providers were not notified.
Exactech expanded the recall on August 11, 2022, to include all Connexion GXL and conventional ultra-high molecular weight polyethylene hip liners manufactured since 2004. This time, Exactech notified health care professionals and instructed them to notify patients.
The recalled hip replacement components include the following:
- Acumatch GXL Acetabular Liners
- MCS GXL Acetabular Liners
- Novation GXL Acetabular Liners
- Exactech All Polyethylene Cemented Acetabular Cup
- Acumatch Conventional
- MCS Conventional
- Novation Constrained Acetabular Liners
Medically Reviewed By: Patricia Shelton, M.D.
Legally Reviewed By: Rebecca Phillips
Recalled Knee and Ankle Implants
On August 30, 2021, Exactech issued a recall of the knee and ankle implant devices but, according to the MDL complaint, did not notify health care providers until February 7, 2022. Exactech issued a correction on April 7, 2022.
The recalled knee and ankle implants include tibial inserts and components in the following Exactech product lines, all of which contain polyethylene:
Why were Exactech implants recalled?
Evan M. Janush:
As the managing attorney of the New York office of The Lanier Law Firm, I’ve often been asked, “What makes exact tech claims different from past product liability claims concerning medical implant devices such as, for example, the Pinnacle Hip made by DePuy that The Lanier Law Firm led litigation efforts concerning?” And the answer is fairly straightforward. Unlike in those other product liability cases dealing with hip implant and other knee implant litigations that our firm has been litigating for many years, in this case, in the exact tech scenario, this company may have known for as long as 17 years that they failed to appropriately package their product in a way that would preserve the polyethylene plastic implant component so that it would not be subject to oxygenation or oxygen. When subjected to oxygen, the polyethylene may degrade. And when that degrades, it’s degrading post-implant in someone’s body, whether that’s in a hip, a knee, or an ankle, to an unwitting victim who simply thought that they were getting a device that would enable them to walk better, to live better, to be more athletic, et cetera. And so, this isn’t a metal on metal claim where a metal hip femoral head was rubbing against a metal acetabular cup creating cobalt, chromium poisoning or particulate to enter the bloodstream. This is a very different case. This is not a case addressing that the design of the actual implant was flawed, negligent, or irresponsible. Instead, this is really a case addressing how the packaging and the shipment, the storage of this product, was irresponsible, negligent, and led to injury.
The recalled devices contain polyethylene inserts, cups, and liners, which can degrade when exposed to oxygen. To prevent this, the company is required to package the products in oxygen-resistant vacuum bags with a secondary barrier layer of ethylene vinyl alcohol for added protection.
While Exactech did package the products in vacuum bags, the bags lacked the secondary barrier layer. Exactech has admitted that 80 percent of the inserts manufactured since 2004 were placed in non-conforming packaging. This allowed oxygen to reach the polyethylene components and begin degrading the material.
On March 23, 2023, the FDA released an official safety communication reminder to patients regarding Exactcech joint replacement devices manufactured between 2004 and August 2021 and recalled in 2021 and 2022.
Exactech Joint Replacement Failure Rates
The Master Personal Injury Complaint filed in the federal MDL cites a 2015 analysis by the Australian Joint Registry, which found that Exactec’s Optetrak PS had a 19.4 percent failure rate after just seven years and a 10-year failure rate of 22 percent . Another Exactech product, the Optetrak Finned Tibia Tray, had the worst failure rate of any implant marketed in Australia.
Symptoms and Complications of
Defective Joint Replacements
When these products wear inside the human body, microscopic pieces of the components come off and enter the surrounding bone and soft tissue. This can lead to the following:
- Osteolysis – Loss of bone tissue
- Muscle, soft tissue, or bone necrosis – The irreversible death of bodily tissues
- Periprosthetic fluid collection – The buildup of fluid around the joint replacement
Osteolysis is the most common cause of joint replacement failure, according to Stanford Medical Center. As bone tissue wears away, the implant may loosen. People with osteolysis are also more prone to fractures. Unfortunately, symptoms often do not emerge until after the damage is done.
Symptoms of a Failing Joint Replacement
The signs and symptoms of a failing joint replacement may include the following:
- New or worsening pain
- Inability to bear weight
- Grinding or other noise
Complications from Defective Polyethylene Implants
Plaintiffs in the Exactech MDL have experienced the following complications, according to the Master Personal Injury Complaint:
- Impaired mobility
- Physical disability
- Loss of use of a limb
- Permanent disfigurement
- The need for revision surgery
Revision surgery is the repair or replacement of the joint replacement device. During surgery, the original joint replacement device must be removed. This can be a painstaking process because it may have fused with the bone. If cement was used in the original surgery, this must be removed. If you have experienced bone loss because of osteolysis, the bone structure may require a rebuild.
According to Experimental and Therapeutic Medicine, this type of surgery requires additional planning and skill. It is technically difficult and associated with worse outcomes and a longer recovery period than a primary joint replacement surgery.
How can I determine whether I received a
Exactech has provided a website where you can enter the serial number of your implant to determine whether it is one of the recalled items. If you do not know whether you have an Exactech implant or if you do not have your serial number, your surgeon should be able to provide it. Your surgeon can also advise you on whether your implant is part of the recall.
What should I do if my implant is included in the recall?
If your implant is included in the recall, you should speak to your doctor. If you are experiencing symptoms related to your joint replacement such as swelling, pain, or grinding noises, your doctor should perform imaging tests to determine if your joint replacement is failing.
If you do not have symptoms and your joint replacement is functioning well, due to the asymptomatic nature of osteolysis, your doctor may opt to perform diagnostic tests to ensure you have not experienced bone loss.
If you have experienced joint damage as a result of defective Exactech implants, you should contact an experienced products liability lawyer as soon as possible.
The Lanier Law Firm’s Record of Historical Success in Joint Replacement Litigation
The Lanier Law Firm has been standing up to large companies on behalf of injured individuals for 33 years. We have won more than $20 billion for our clients, including historical success in hip implant litigation against DePuy Orthopaedics, a subsidiary of Johnson & Johnson, in the Pinnacle Implants MDL:
- $502 million on behalf of our Texas clients in a bellwether trial
- More than $1 billion for our California clients
- $247 million combined verdict on behalf of six New York plaintiffs
- $1 billion global settlement on behalf of nearly 6,000 remaining cases in the MDL
We also won a $56 million verdict against Biomet for defective metal-on-metal hip implants.
Our law firm was founded in 1990 by Mark Lanier, one of the most prominent and feared trial lawyers in the United States. He is recognized by The New York Times as “one of the top civil trial lawyers in America.” The Trial Lawyer magazine and the National Law Journal recognize Mr. Lanier as one of America’s most influential trial lawyers.
The Lanier Law Firm is home to more than 60 attorneys who are passionate about providing serious and sound representation to injured people. This is how we are redefining legal care. We are a U.S. News Tier 1 Best Law Firm, and several of our attorneys have earned the following accolades from the legal community as a result of their commitment to our clients:
- Super Lawyers
- Top 100 National Trial Lawyers
- Best Lawyers in America
Featured Attorney Rebecca Phillips
Rebecca Phillips is an experienced pharmaceutical liability lawyer who has been recognized in the Top 40 Under 40 by the National Trial Lawyers for the past several years. Ms. Phillips has been named to the prestigious Lawdragon 500 Leading Plaintiff Consumer Lawyers. She has also been named a Superlawyers rising star for the past two years. She earned her law degree at Yale Law School.
How much compensation can I recover in an
The Exactech litigation is in early stages, so there have yet to be any settlements. The compensation available in your Exactech recall lawsuit may be affected by the severity of your injury and by the outcome of the bellwether trials.
The compensation sought in the litigation includes the following:
- Economic damages – Medical expenses and lost wages
- Non-economic damages – Pain, suffering, and loss of consortium
- Punitive damages on the grounds that Exactech’s conduct was “malicious, reckless, wanton, fraudulent, beyond all standards of decency, and without regard for human life or plaintiffs’ rights.”
Evan Janush: We’re often asked by clients, what do you, as an attorney who’s skilled in bringing product liability cases, expect an ultimate settlement range to be? And unfortunately, we just don’t know. We’re not in a position to predict. I often tell people, we both have discussed this, Alex, before, that we wish we had a litigator’s crystal ball and that we could look through it and see down at the end of the road what a case will settle for. So instead, I pivot and I address the very plain reality, which is this. If you want the best possible outcome, come to the Lanier Law Firm. We get great results.
What are the grounds against Exactech?
According to the Master Personal Injury Complaint, the case against Exactech is based on the following:
How much time do I have to file an Exactech lawsuit?
The time limit to file an Exactech lawsuit varies based on the statute of limitations in the state where your case originates. In some states, the statute of limitations begins to accrue when you became injured or became aware of the injury, so it is important that you not wait too long to file.
In this case, plaintiffs are asserting that the statute of limitations should be tolled to the date Exactech issued the recall and released the scientific and technical information about the mechanisms of injury. This is based on the discovery rule in connection with the latency of injuries and the allegation of fraudulent concealment.
When should I contact an attorney?
The defendants may dispute the tolling of the statute of limitations as described in the master complaint, and the court will have to make a decision. Thus, it is not certain when the clock may begin. But if you do not file your Exactech lawsuit before the statute of limitations expires, you may permanently lose your right to pursue damages. The safest action is to contact an attorney as soon as possible.
How can The Lanier Law Firm help?
When you retain our law firm, we will conduct a thorough investigation of your claim. This will include retrieval of your medical records and consultations with medical experts. This will help us accomplish the following:
- Establish a causative link between the implants and your injuries
- Calculate your case value
- Prepare a persuasive case
- Timely file your case
We will stay in contact with you throughout your case and answer your questions as the litigation moves through the MDL. We provide free case evaluations, there are no upfront costs to you when you retain our law firm, and you won’t be charged for our services unless we are able to obtain compensation for your injuries. Contact us today to schedule a free consultation.