Symptoms of a Defective Knee Replacement Device
If you’ve been experiencing any of the following symptoms, contact your health provider for a device evaluation:
- New or worsening swelling
- Pain while walking
- Joint instability
- The inability to put your weight on your artificial joint
- Grinding, clicking, or other sounds of problems with joint operability
As a patient who may be the recipient of a defective medical device, it’s your right to speak to a lawyer to find out more about whether you qualify for compensation through a claim.
Recalled Exactech Knee Replacement Devices
In early 2022, hundreds of thousands of Exactech patients received a recall letter from their doctors causing them worry and leaving them with many unanswered questions. Many patients are unsure whether this recall applies to them and what they need to do next.
The defective medical device attorneys at the law firm of Goldstein, Buckley, Cechman, Rice & Purtz, P.A. want to answer your questions in a free legal consultation. Let us help you determine if you are eligible for monetary compensation due to the Exactech knee replacement lawsuit.
When Were the Devices in Question Implanted?
Exactech announced a recall in February of 2022, of 147,000 knee and ankle replacement devices implanted in patients between 2004 and 2022.
What’s Wrong with the Defective Products?
The recalled products contain polyethylene liners (plastic inserts). These liners are used in knee and ankle replacement devices and can wear down prematurely, leading to the failure of the joint and the need for early replacement. Even worse, these liners often destroy tissue and bone as they prematurely degrade and shed microscopic particles not intended to be released into the human body. Many patients experiencing issues due to degradation of the product liner must undergo an additional surgery to correct the problem.
How Did This Happen?
Inadequate packaging of the liners allowed oxygen exposure before they were implanted into patients. The lack of an ethylene vinyl alcohol (EVOH) oxygen barrier layer in the packaging allowed oxidation to degrade the liners, causing them to wear out sooner than expected.
Which Devices Are Involved in the Knee Implants?
The Exactech knee replacement recall involves the following devices, sold between 2004 and 2022:
- Optetrak Logic
Patients with Other Defective Exactech Devices May Also Qualify
In addition to the knee replacement devices listed, Exactech faces litigation for its ankle and hip replacement devices, distributed throughout the United States. It is imperative that patients find out if there may be a problem with an Exactech device they have received and if they are due compensation.
Recalled Exactech Hip Replacement Devices
Exactech has recalled its Connexion GXL liners used in hip surgery under the following names:
Generally, hip replacements are made to last 25 years or more. Minimally, they should last 10 years, but in the case of a defective implant, the device has the potential to fail much earlier than expected.
As with the knee liner degradation, debris resulting from microscopic wear in the GXL liner is toxic to human tissue. As particles gather in the area around the prosthetic hip socket, this debris can cause muscle, bone, and soft tissue necrosis (or tissue death). If the bone dies (osteonecrosis), the hip can become unstable, making corrective revision surgery difficult.
Symptoms of Hip Replacement Problems
The most common symptoms of Exactech hip replacement rejection are like those listed for knee replacement symptoms:
- Instability in the joint
It’s important to contact your doctor if you have any concerns about a problem with your hip replacement, as in some cases, rejection can cause breaks or dangerous infections.
Exactech Vantage Ankle Replacement Device Recall
The Vantage total ankle system has been recalled due to its liner being exposed to the same packaging-related degradation problem faced by the knee and hip devices. As with the other recalls, anyone who received one of the recalled ankle replacement devices and is experiencing medical complications may be entitled to compensation. We encourage you to reach out as soon as possible for a free legal consultation.
How Long Do I Have to File a Lawsuit against Exactech?
The time windows may vary from state-to state, but generally, you have four years in the state of Florida from the point at which you are aware of a problem with your device. Because it can be difficult to define this window with exactness, it’s important to consult with our Exactech recall attorneys as soon as possible to protect your right to pursue compensation.
How a Lawyer Can Help with Your Claim
Mass tort claims can be overwhelming without the guidance of an attorney, and medical device product recalls are complicated. Our medical device lawyers can help you cut through the “red tape” of dealing with a mass tort case involving multiple types of joint replacement systems.
If you are facing the need for corrective surgery because of a faulty device, having someone to advocate for you can make all the difference in receiving the compensation you are owed. Contact our experienced Exactech recall attorneys to get answers about your situation and determine your eligibility for participation in a recall claim. We offer a free no-obligation consultation so you can get the answers you need.
How to Prepare Yourself for Your Free Legal Consultation
If you’ve been dealing with pain or functionality problems regarding your Exactech device, please read through the steps below to help prepare yourself to learn more.
Gather Your Paperwork: Collect your documents and medical records regarding your joint replacement. Although you don’t have to have a recall letter to file a claim, if you did receive one, bring that as well.
Also bring any work records you have regarding work hours you may have lost due to the inability to work because of your defective joint. If you are unsure whether a document is relevant, it’s best to include it, just in case.
Keep Following Your Doctor’s Instructions: While exposure to oxidation causes degradation in Exactech devices over time, there is currently no universal instruction for all recipients of these devices to undergo immediate revision surgery. Continue to adhere to the advice of your doctor until your specific condition is evaluated. While you may need revision surgery in the future, your doctor will need to examine your joint to determine how best to proceed.
Reach Out: Call us to schedule a free legal consultation. Our experienced legal team is ready to provide you with answers about the recalls for defective Exactech joints.
Exactech Recall Client Story
We are including the story of a client to further illustrate aspects of the Exactech lawsuit. Names and specifics have been edited to protect the privacy of our client, but the value of the information remains. Please read through it and then reach out so we can provide you with answers about your own claim.
In a Lehigh Acres warehouse in February not so long ago, a shipping specialist, Pat Riley, stumbled. It was almost the end of her shift. She caught herself at the last second, wrapping her arm around a nearby support beam as she fell. A jolt of pain shot through her shoulder. She’d be bruised but was otherwise okay.
The single mom had been moonlighting for three years now to keep up with her son’s college tuition. So far so good. In just over a year, he’d have a degree, and she’d sign off what was left of his federal loan to him to pay off. She’d kept up with the payments so far through frugality and elbow grease.
She straightened, rubbing her shoulder. All good, so long as she didn’t land on what she almost always jokingly called her “bionic knee.” It had been almost three years since she’d finally had it replaced.
The cartilage in her natural knee had eroded over the years, leaving her with daily nagging pain and joint instability. She’d made sure when she’d applied for the night work that the position did not involve lifting.
“The heaviest thing you’ll be lifting is a clipboard,” her interviewer had said. He’d kept his promise, and she’d done well. She enjoyed the work and was able to move around during her shift instead of having to sit chained to a desk. What was it they said these days? Sitting is the new smoking.
At 54-years-old, Pat was healthier than most 30-somethings she knew. Her healthy diet and joint-friendly activities were geared toward longevity, not dazzle. Even so, in her early 50s, she’d needed the knee replacement. After she’d exhausted all other avenues of rehabilitation, she’d given in and had knee joint replacement surgery.
According to her doctor and all she’d read about the Exactech knee device, it was nothing short of a miracle. No more pain. She’d be back to her active self “in no time.”
At least, that was the promise.
Her excellent health enabled her to recover relatively quickly, and she’d been able to get back to work—and life—free of knee pain. At least until a month ago.
It had begun with burning pain that seemed to come on in the middle of the night, waking her. She’d thought it odd, since the discomfort came when she was finally at rest.
The sleep disruption frequently left her unable to get back to sleep for hours. With an alarm set for 5:30 a.m. daily, by the time Pat finally fell back asleep, it was almost time to get up. She wasn’t getting deep, restorative rest and was waking up disoriented and exhausted.
Nothing seemed to fix the issue entirely. She’d begun taking over-the-counter pain relievers before bed, unwilling to consider a prescription pain reliever. They worked only to a point and always upset her stomach. If a burning knee didn’t wake her, a burning stomach did.
Then she began to experience intermittent sharp pain in the joint during the day, though it was too random to connect with any specific movement. Without knowing what the cause was, Pat had no idea what to change in her movements to prevent it. She began wearing a soft knee brace to provide additional support while she was on her feet.
But the joint instability was the last straw. This stumble was the second time her left knee had randomly given out on her in the past week. The first time the knee had buckled, she thought she’d just been clumsy, though clumsy had never been one of her traits. When it happened a second time, she gave up hoping the issue would resolve on its own, and she made an appointment with her doctor.
The day before her appointment, the letter arrived. Exactech was recalling three of their knee replacement devices, and hers was on the list. She went online and found the law firm of Goldstein, Buckley, Cechman, Rice & Purtz and scheduled a free legal consultation.
How much does it cost to hire a lawyer?
As Pat sat down with Attorney John B. Cechman three days later, he noticed her using her arms to bear her body weight as she carefully lowered herself into the chair.
“Is your knee joint unable to support your weight right now?” he asked, concerned.
“To be honest, I’m not sure,” she answered. “But I’m not taking the chance. It’s given out on me twice in the last ten days, and I don’t trust it.
“But before we talk about a potential claim though, may I ask what it costs to hire your firm? I understand this consultation is ‘free,’” she said, using air quotes. “But I’ve got to know all the facts up front. My son is in his junior year of college, and I have the sinking feeling I may need revision surgery on my knee.”
“I understand completely,” said Attorney Cechman. “Our law firm works on a contingency-fee model. This means that we front all costs during your claim. You do not pay any out-of-pocket expenses. When your claim is resolved, we only receive compensation when we’ve successfully resolved your claim for you.
“And this consultation is truly a free, no-obligation opportunity for you to ask questions—no air quotes necessary.” He smiled. “So, ask away.”
Do I qualify for a claim?
“Great, thank you. I’d like to start by finding out whether I qualify for a claim,” said Pat. “My device was implanted almost three years ago, so it falls within the window listed in the letter, between 2004 and 2022. I was already experiencing a problem with the joint when the letter arrived, so I came in for answers.”
“Very smart move,” said Attorney Cechman. “It’s critical for you to know your legal rights regarding this recall. Joint replacement device manufacturers have a legal obligation to ensure that their products are safe and do not cause harm.
“Exactech acknowledged through their recall that certain products were defective and are subject to high failure rates. As a result, these failures can cause pain and tissue damage, requiring additional surgery. If you are a patient with a failed, recalled Exactech implant, you are eligible to file a product liability lawsuit against the manufacturer,” said Cechman.
What kind of damages are available?
“So far it sounds likely I’ll qualify,” said Pat with a sigh. “My doctor did an MRI of the knee yesterday. I’m waiting for the results, but based on my symptoms, he suspects there may be a problem with the implant.
“What kind of damages are involved in a claim like this? If it turns out I need revision surgery, I’ll be missing work from both of my jobs. And as if that’s not going to make things tough enough, I can’t imagine dealing with the recovery process all over again.
“I know I’ve got to do something. The pain and lack of joint stability are bad enough, but the sleep deprivation is destroying my quality of life. I’ve got brain fog, and I’m becoming an emotional mess,” Pat said, wiping an angry tear from her cheek.
“You must be exhausted,” Cechman agreed. “The fallout of sleep deprivation can be devastating. And in answer to your question, compensation is possible for medical expenses, lost wages, and other economic damages, but can also include monetary damages for non-economic damages, such as pain and suffering, and emotional distress.
“One of the significant benefits of hiring an attorney is their ability to identify and pursue compensation for all forms of damages incurred because of the defective device—past, present, and future,” said Cechman.
Why not just file a claim through Exactech?
Pat nodded, making notes before continuing. “My next question may sound rude, but that’s not my intention. I simply need everything ‘out on the table,’ so to speak, before moving forward,” she said.
Cechman nodded. “By all means, go ahead. That’s exactly what this consultation is for.”
“The letter I received indicated that Exactech has a process in place for people to make a claim directly through the company. Why would that not be the simplest and likely least expensive way for me to go?”
“Great question,” said Cechman. “You are correct that Exactech has a claims process available for patients. But there are several reasons we would not suggest moving forward directly with the manufacturer.
“For one thing, patients who file a claim directly with Exactech are likely to waive their right to file a product liability lawsuit against the company in the future.
“This is a big deal. The last thing you need is to lose your right to full and fair compensation for things like pain and suffering and other damages the manufacturers are not likely to cover through the claims process they are providing.
“We recommend anyone considering filing a claim directly through Exactech’s claims process without an attorney speak to an experienced Exactech recall attorney in a free legal consultation first. You were smart to come here before making a decision. You should be shown the full picture before moving forward.
“When you retain a skilled Exactech recall attorney, you have someone watching your back to make sure the device company doesn’t get you to sign away your rights without realizing it. We’re talking about your rights to the kinds of damages you can collect in a lawsuit for those ‘other’ types of damages, like pain and suffering.
“Your damages, Ms. Riley, are going to be determined by us based on your specific claim. We will make sure you are compensated for all you have gone through, are going through, and are likely to go through in the future.
“People who hire attorneys almost always receive many times more in compensation than those who knock on the manufacturer’s door by themselves. One of the reasons for this is their attorneys are able to accurately assess the value of their claim and pursue all of their damages.
“An attorney can protect your rights and the value of your claim far better than if you were to simply throw yourself on the mercy of the manufacturer. This is not a situation in which blind trust in the device manufacturer is a smart move.
“When you sat down, you told me you do not trust your knee. Unfortunately, I’ve got several reasons not to trust the manufacturer of the device in your knee, either,” said Attorney Cechman.
“Let’s begin with the fact that Exactech was aware of the problems with its knee replacement devices at least four years before the first partial recall. Did you know the U.S. Federal Food and Drug Administration (FDA) began receiving adverse event reports in 2017?” Attorney Cechman asked.
The shock on Pat’s face told him she did not. He continued. “Exactech should have addressed potential safety concerns related to the devices at that time. Sadly, it would be several more years before they instituted a recall. And that first recall back in 2021 was limited.
“It was not until 2022 that they expanded the recall to include all devices—those currently on hospital shelves, as well as those implanted in patients.
“In addition, you should know that Exactech was granted FDA approval for its knee replacement devices via the FDA’s 510(k) fast-track approval process. This means that they were allowed to receive approval without meeting the standard level of safety testing, because they claimed their new device was “substantially equivalent” to—meaning basically the same as—other products previously approved by the FDA.
“The fast-track approval process is controversial, at best. In this case, Exactech used it to their advantage, and the disadvantage of all the doctors and patients who placed their trust in their product.”
“Shouldn’t my doctor have been aware of the problem with Exactech devices?” Pat asked, incredulous.
“The doctors were notified of the recall in February 2022, at the same time patient notifications started going out. There is no reason to believe they had prior awareness there was a problem with the devices until then,” said Cechman.
“For now, continue to follow your doctor’s advice and be sure to keep all your medical documentation and paperwork about the device and the recall. It sounds like you’ll hear from your doctor soon as to the current condition of your knee and recommended next steps.
“Our firm thoroughly investigates claims before moving forward to ensure we have all the necessary information to proceed to our client’s best result. We would do this in your case as well. Your doctor’s feedback on the MRI results is going to be an important piece of the puzzle, but at this point, you are likely to be eligible for a claim.
“If you decide to move forward, I urge you to do so with a personal injury trial attorney experienced in defective medical device claims. Whether it’s our firm or another, you’re going to want your attorney to be able to fight for your rights at trial should it become necessary to bring you the compensation you deserve,” said Attorney Cechman.
“My mother has a hip from Exactech. Does this problem include hips, too?” Pat asked, worry knitting her brows.
“It does,” said Cechman. “The material degradation causing the problems is present in hip and ankle replacement devices, in addition to knee replacement devices. The Exactech recall attorneys at Goldstein, Buckley, Cechman, Rice & Purtz handle claims for all Exactech devices. If it turns out your mother is having difficulty as well, she can come in for her own free legal consultation. We’d be happy to answer questions about her situation.”
Pat was satisfied with the information she received in her free legal consultation. She retained Goldstein, Buckley, Cechman, Rice & Purtz, and is moving forward in pursuit of compensation for her damages.
Call Our Exactech Recall Attorneys Today
We hope you’ve gotten some helpful insight into your own potential claim against Exactech.
Our defective medical device attorneys handle claims for defective ankle and hip implants, in addition to defective knee devices. If your recalled Exactech joint replacement implant failed and you had to undergo corrective surgery, our lawyers want to help. Call us to get your questions answered in a free legal consultation.