Established in 1994, Exactech has become one of the larger medical device manufacturers across the globe. Specifically, the company is known for its knee replacement implants. Yet, since 2011, the U.S. Food and Drug Administration (FDA) has received complaints of Exactech’s Optetrak knee replacement implant failing.
The Optetrak knee replacement implant was just one of many products which were “fast-tracked” through the FDA approval process in what was known as a 510(k). The 510(k) process can be beneficial to patients by bringing well tested medical devices to market, however, this often means less testing on the device is done. In the previous decade, we have represented thousands of individuals who, just like yourself, have medical devices which have failed and were a part of the 510(k) process.
Do you currently suffer from an Optetrak knee replacement complications? Did you receive an Optetrak knee replacement implant during or after the year 2011? If so, you may be eligible for a Exactech Optetrak knee replacement lawsuit against the manufacturer to compensate you for unexpected medical expenses, loss of work, pain, and other interruptions due to revision surgery. Should you have a question at any time while reading this page, call to schedule a free, no-obligation consultation with an Exactech Optetrak knee replacement lawyer.
Did Your Optetrak Knee Implant Fail?
Each year in the United States, approximately 700,000 knee replacement procedures are performed. By the year 2030, the number of knee replacement procedures performed is projected to increase to 3.48 million annually. These surgeries are often pursued by patients who have damaged knees due to arthritis, severe injury or excess wear and tear on their body.
When performed correctly, and with a safe and reliable product, a knee replacement surgery can offer a variety of benefits, such as up to 15 years or more of pain-free stability and mobility assistance. Yet, if the knee replacement implant fails, complications can occur. These complications can take place immediately or years after the initial surgery depending on your body type and usage of the knee implant.
Though Exactech has been producing knee replacement implants for more than 30 years, the Optetrak knee replacement versions released prior to 2011 were different from past models, as they featured a “finned” tibial tray, which may not promote adequate adherence to surgical cement. In September 2011 a Class 2 recall was issued for the Optetrak knee replacement implant. The FDA report can be found here.
Later, in 2013, Exactech changed their Optetrak knee replacement implant to a “fit” tibial tray, which may achieve better long-term results than the previous finned tibial tray version.
As stated above, since 2011, the FDA has received significant complaints regarding Exactech’s Optetrak knee implant, and the product’s failure, which could require a painful and inconvenient revision surgery. If your Optetrak knee replacement implant resulted in complications, an Exactech Optetrak knee replacement lawyer may be able to help you receive compensation for pain and suffering resulting from your implant’s failure.
Common symptoms of an Optetrak knee implant failure include:
- Infections, inflammation, swelling, and pain
- Loss of mobility
- Reduced range of motion
- Disassociation of implant
- Change in component position
- Instability or trouble balancing
The Exactech Optetrak Knee Replacement Lawsuit
Recently, the first Exactech Optetrak knee replacement lawsuit was filed in Georgia against Exactech, claiming the company knew that the components in its product were susceptible to early complications. In the Exactech Optetrak knee lawsuit filed by the knee replacement lawyers of Childers, Schlueter & Smith, it is stated that the plaintiff underwent surgery to implant an Optetrak knee replacement that was defective, dangerous and caused permanent damage. When the knee implant failed, a painful revision surgery was required.
Optetrak’s failure has been attributed to a finned tibial tray insert that was not able to endure stress placed on the joint, setting it apart from previous, more successful models. Further, the lawsuit states that by 2012, the company had noticed that the rate of finned tibial tray failure on Optetrak knee implants was increasing at an alarming rate.
The Manufacturer and User Facility Device Experience (MAUDE) reports indicate revision surgeries were needed due to the faulty knee replacement implants, which led to patients having the implant removed. Other, similar complaints were received in 2013 and 2014, leading to Exactech allegedly conducting a “silent recall” campaign, in which the company slowly replaced all finned tibial trays with a new design.
“The fact that Exactech made this “silent recall” device replacement indicates the company knew – or should have known – about the failures of their Optetrak knee replacement product, and that it was not safe for patients.”
It’s alleged that Exactech did not properly or thoroughly test the Optetrak knee replacement implant before it was put onto the market. Further allegations state that Exactech did not thoroughly analyze the data from the pre-market tests, and did not conduct either the proper post-market tests or sufficient follow-up tests.
Our Exactech Optetrak knee replacement lawyers are diligently conducting further investigation into the Optetrak knee implant and, specifically, our clients’ knee replacement complications. Following our investigations, the knee replacement attorneys of Childers, Schlueter & Smith can file claims and lawsuits on behalf of our clients against the manufacturer.
This is not the first time Exactech has come under fire for its ethics or products. Back in 2010, the company settled with federal prosecutors for $3 million as a result of kickbacks given to surgeons. Then, in 2013, the company had a list of product recalls involving hip and shoulder replacement devices.
Now, Exactech is facing problems with its Optetrak knee replacement implant. An Optetrack study reported a number of patients dissatisfied with their knee implant, with a significant amount showing signs of pain, patellofemoral conflict and the need for revision surgery.
Do You Have an Optetrak Knee Replacement Implant?
If you received an Optetrak knee replacement implant during or after the year 2011, and have since experienced unusual complications, such as swelling, fractures, infections or any of the negative side effects detailed above, then you could be eligible to file an Exactech Optetrak knee replacement lawsuit. If you are unsure, that’s OK. It’s common to be unsure of the product and model. Our Exactech Optetrak knee replacement attorneys are here to listen to your case and help determine your eligibility for a knee replacement lawsuit.
During this time, it is imperative to remember that you are not alone. The knee replacement attorneys at Childers, Schleuter & Smith have decades of experience working with clients who are just like you: those who put their trust into a company, only to have that trust broken, resulting in pain and suffering.
For any type of irregular pain or discomfort you may have experienced from your Optetrak knee implant failure, it is necessary to contact your doctor. Not only can your doctor help you move forward from this pain and discomfort, but also give you access to your medical records, indicating which device and model number were used for your knee replacement surgery. You may also call a knee implant lawyer at any time to discuss your knee replacement, the symptoms you are suffering and what next steps you may consider. Receiving a legal consultation from an Exactech Optetrak knee replacement lawyer will help you to better understand your options and how long you may have to take action. In all 50 U.S. states, there are statutes of limitations that can prevent you from pursuing legal recourse. Our knee implant attorneys offer confidential consultations available at no cost.
While pursuing an Exactech Optetrak knee replacement lawsuit may be the last thing on your mind right now, know that compensation can help assist with the following:
- Lost wages
- Revision surgery
- Pain and suffering
- Long-term medical care
- Past or future hospital bills
- The loss of any future earnings
- Permanent disability and quality of life
Not only should Exactech be held accountable for their actions and knee implant failure, but you deserve to live a healthy, pain-free life. Let us help you.
Contact the Knee Replacement Attorneys at Childers, Schleuter & Smith Today
With decades of combined experience, and more than $450 million recovered nationwide for our clients, the Exactech Optetrak knee implant lawyers at Childers, Schleuter & Smith have the skills and determination to help you move forward. Unfortunately, Exactech manufactured and marketed a faulty Optetrak knee replacement product, which has since affected your quality of life. Let a knee replacement attorney help provide you with the answers and a roadmap to recovery that can get you back to enjoying life.
To schedule a no-cost, no-obligation consultation, contact Childers, Schleuter & Smith today by calling (800) 641-0098. You have been through more than enough, let us help.