Defective Medical Device Injury
Exactech Knee Recall
If you’ve endured an ankle or knee replacement surgery between 2004 and 2022, listen up. Many medical device manufacturers have recalled their knee replacement implants over the last decade, but the latest recall comes from Exactech. In fact, the Food and Drug Administration has issued a Class II Exactech knee recall.
Faulty knee replacements can cause major physical and financial consequences. You could endure months or years of pain before you finally have the money to undergo another knee surgery. In some cases, defective medical devices force people to spend decades paying off medical debt. No one deserves this kind of physical and financial struggle. That’s why you need an experienced knee replacement lawyer from Janicek Law on your side. We’ll protect your rights while fighting for maximum compensation. Call 210-366-4949 to file an Exactech knee implant lawsuit.
Why Did Exactech Recall Its Knee Replacement Devices?
In short, the Exactech recalled ankle and knee implants due to packaging failure. The packaging failure exposed the medical devices to too much oxygen before surgeons implanted them into patients’ bodies. Oxidation basically breaks down the polyethylene insert in medical devices like hip and knee implants. As a result, patients can experience severe pain and other complications, eventually causing them to undergo knee revision surgery.
FDA Class II Recall
According to the Food and Drug Administration (FDA), the Exactech recall is classified as a Class II recall. The definition of a Class II recall from the FDA is:
In other words, device failure is certainly possible but it’s unlikely to cause serious complications.
Did Exactech Obtain 501k Clearance From the FDA?
Yes, and this may be a partial explanation as to why so many Exactech devices have failed. 501k clearance basically shortens the FDA approval process. Companies who register their products for 501k clearance do so because they believe that their products are safe and effective. Therefore, the companies believe their products don’t need to go through the whole FDA approval process to determine safety and effectiveness. Had Exactech medical devices gone through the whole FDA approval process, maybe they would’ve discovered the packaging failures that led to oxidation and breakdown.
Did Exactech Know About Its Defective Implants?
The FDA began receiving faulty knee implant reports associated with Exactech in 2017. This means that the company should have been aware of the potential health dangers caused by its knee replacement systems.
Which Exactech Devices Were Recalled?
The Exactech company recalled multiple ankle and knee replacement systems sold between 2004 and 2022. This is according to an urgent medical device correction that was released in February 2022.
Knee Replacement Devices
Exactech recalled Optetrak Unicondylar Tibial Components which are used for partial knee replacements. The recalled knee replacement implants listed below have been used for total knee replacements.
- Optetrak All-polyethylene CR Tibial Components
- Optetrak All-polyethylene PS Tibial Components
- Optetrak B-series PS Tibial Insert
- Optetrak CC Tibial Inserts
- Optetrak CR Tibial Inserts
- Optetrak CR Slope Tibial Inserts
- Optetrak PS Tibial Inserts
- Custom Optetrak Angled PS Insert
- Custom Optetrak CC Tibial Insert
- Optetrak Hi-Flex PS Tibial Inserts
- Optetrak “Momb” Non-Mod Molded Insert
- Optetrak RBK PS Tibial Components
- Optetrak Logic CR Tibial Components
- Optetrak Logic CR Slope Tibial Inserts
- Optetrak Logic CRC Tibial Inserts
- Optetrak Logic PS Tibial Inserts
- Optetrak Logic PSC Tibial Inserts
- Optetrak Logic CC Tibial Inserts
- Truliant CR Tibial Inserts
- Truliant CR Slope Tibial Inserts
- Truliant PS Tibial Inserts
- Truliant PSC Tibial Inserts
More than 120,000 Optetrak and Optetrak Logic knee replacement devices have been sold and implanted into Americans since 2004. Meanwhile, only 24,000 Americans have had the Truliant devices implanted since 2004.
Ankle Replacement Devices
The only ankle replacement system that Exactech recalled is the Vantage Fixed-Bearing Liner Component which was introduced in the U.S. in 2016. Approximately 1,500 of these implants have been sold and implanted into Americans.
Exactech Knee Replacement Recall Symptoms
If you have an Exactech knee replacement implant and you’re experiencing any of the symptoms below, you may need another knee surgery.
- Persistent knee pain while walking, standing, running, etc.
- Clicking or grinding sounds coming from your faulty knee implant
- General knee instability
- Knee swelling and stiffness
- Inability to put weight on your knee implant
What Should I Do if I Have an Exactech Knee Replacement Device?
If you endured knee replacement surgery and received an Extractech knee system between 2004 and 2022, you may get a letter from your orthopedic surgeon about the recall. If not, you should certainly make an appointment with your doctor to talk about potential knee implant failure. They will monitor your knee replacement system closely just in case you experience device failure. If you’re not experiencing persistent pain or any of the other aforementioned symptoms, there’s no need to undergo revision surgery yet.
Other Knee Replacement Manufacturers That Have Issued Recent Recalls
Unfortunately, Exactech isn’t the only medical device manufacturer to issue a recall. If you’ve experienced pain after receiving an implant from one of the companies listed below, you have grounds to file a knee replacement lawsuit.
- Arthrex iBalance Knee: Recalled in 2015 due to tibial tray loosening, which led to knee replacement failure and revision surgery.
- B. Braun Advanced Surface Ceramic Coated Knees: Recalled due to component loosening.
- DePuy Attune Knee System: These knee implants were never officially recalled. However, thousands of people filed knee replacement lawsuits against DePuy due to component loosening.
- Zimmer Biomet NexGen and Persona Knee Systems: Recalls were issued in 2010 and 2014 due to component loosening.
- Stryker Duracon Unicompartmental Knee System: Recalled due to knee stiffness, pain, and instability.
- Smith & Nephew Journey I BCS Femoral and Tibial Inserts: These knee components were recalled in 2018, and later discontinued, due to component loosening.
If you’re experiencing a failed knee replacement from any of the aforementioned companies, contact the defective medical device attorneys at Janicek Law. We’ll fight for the compensation you need to cover a revision surgery.
Are Doctors Allowed to Use Recalled Knee Implants in The Future?
In short, no. Whenever device manufacturers recall replacement knees (or any other defective medical device), they send out a letter to doctors to warn them not to use the devices in future knee replacement surgeries. From there, doctors will often notify their patients who have received the recalled device. If doctors continue using any recalled medical device or product on their patients, they could face a medical malpractice lawsuit.
How Much Time Do I Have to File an Exactech Knee Implant Lawsuit?
People with defective artificial knees generally have 2 to 4 years to file knee replacement lawsuits, depending on where they live in the United States. But the Texas statute of limitations for defective medical devices is 2 years. In other words, you have 2 years from the day of your knee implant failure (or 2 years from the day you found out about the recall) to file a lawsuit.
Damages for Exactech Knee Recall
If you file a lawsuit for your Exactech knee implant failure, you could recover the types of damages listed below.
- Medical Bills associated with your original knee replacement surgery and your revision surgery.
- Physical Therapy Bills associated with your original knee replacement surgery and your revision surgery.
- Lost Wages if your surgeries forced you to take time off work.
- Loss of Earning Capacity if your knee pain prevented you from accomplishing some of your normal work duties.
- Physical Pain and Suffering associated with your surgeries.
Knee Replacement Lawsuit Settlement Amounts
Most people who win knee replacement lawsuits receive a settlement between $100,000 and $200,000. However, your individual settlement amount will vary depending on the losses you’ve suffered as a result of your defective knee system. For example, let’s say you experienced bone death as a result of your knee replacement system. This is a major (and fairly uncommon) complication that can cost you thousands of dollars in expensive medical treatment. Additionally, you could experience lifelong pain and disability associated with this bone death. These losses would likely result in a fairly large settlement.
What is the Largest Settlement for Knee Implant Failures?
According to a 2002 Wall Street Journal Report, one of the largest settlements due to knee system failure was $1 billion. Americans filed approximately 4,000 lawsuits against Sulzer Medica, which changed its name to Centerpulse after the massive recall. In 2003, Zimmer bought the company for $3.2 billion.
Hundreds of patients experienced complications due to implant loosening that forced them to undergo knee revision surgery. As a result, the company paid approximately $200,000 to each patient who filed a lawsuit.