Exactech Knee Replacement Lawsuits

cartwrightlaw - November 22, 2022 -

Do you have an Exactech knee replacement? In February 2022, Exactech issued a recall for hundreds of thousands of ankle and knee replacement devices that were implanted between 2004-2022. 

These medical devices lacked enough packaging to protect them from oxygen before they were implanted. Oxidation causes the artificial joints to degrade over months and years. As a result, many patients with Exactech knee replacements are left with severe pain and may need revision surgery. 

The Cartwright Law Firm, Inc. has years of experience and impressive results handling knee implant clients. Learn more about Exactech knee replacement lawsuits, then contact us with questions. 

About Exactech

Exactech is a large medical device firm that makes artificial knees, hips, ankles, and other devices. The business also manufactures arthroplasty inserts for many knee replacements. 

The knee replacement made by Exactech is used in thousands of knee surgeries annually. The procedure is called total knee arthroplasty or TKA. A complete knee replacement uses a device to replace the damaged joint entirely. 

However, TKA is usually appropriate for treating chronic knee pain and arthritis. TKA also can be used to improve knee deformities and trauma. Unfortunately, the company has several implant replacement systems that have been recalled. 

In early 2022, Exactech issued a medical device correction that addressed their previous device recall. The recall involves all knee and ankle arthroplasty inserts that were placed in non-conforming vacuum bags. As a result, the FDA classified this recall as Class II. 

Why Was There An Exactech Knee Replacement Recall? 

The recall for these devices was because of a packaging failure. It’s critical for the devices not to contact oxygen before they are implanted. For example, these devices should be carefully packaged to avoid oxygen contamination while being shipped or stored. 

The layers of packaging for the knee inserts were determined to have allowed oxygen contact before they were inserted. The result was oxidation and rapid wear. The inserts that were shipped in the last eight years were in vacuum bags that are oxygen resistant. However, Exactech did not include a barrier layer with ethylene vinyl alcohol that enhances oxygen resistance. 

Many recipients of Exactech knee replacements received a letter about the recall. What should they do to learn if the recall affects them? Our product defect attorneys at The Cartwright Law Firm, Inc. can help you find out if you are affected by this recall. 

Exactech Knee Implant Complications

Exposure of the device to oxygen before it is implanted leads to oxidation. Plastic in the device can wear faster or even become damaged. The oxidation process may lead to premature joint failure. Some symptoms Exactech patients have endured include: 

• Swelling of the knee
• Severe pain while walking
• Difficulty putting weight on the affected limb
• Clicking or grinding in the device
• Knee instability
• Nerve damage 
• Device loosening

Sadly, premature wear in the joint can necessitate follow-up surgery to correct or replace the device. This may mean you must have another major procedure requiring months of painful recovery. If this happens, you could be entitled to compensation in a knee replacement lawsuit. 

Essential Facts About Exactech Knee Replacements

If you think this recall affects you, below are more essential details to know: 

Exactech Recalled Every Optetrak And Truliant Knee Replacement Implanted Since 2004

The knee replacement recall is for all Opetrak, Optetrak Log, and Truliant knee replacements sold from 2004-2022. So, at least 150,000 of the devices are under recall. If you have had one of these devices implanted in the last 18 years, you should check with your surgeon to find out if you need another surgery. 

Exactech Started Recalls in 2021

Exactech recalled Optetrak, Optetrak Logic, and Truliant devices in 2022, but a smaller recall started in 2021. The first recall was only for devices with five or more years of shelf life.

 However, the recall now covers all knee replacements, including devices put in patients and those still sitting on shelves at the hospital. 

Exactech Knew About The Problems

FDA started to receive adverse event reports about the devices in 2017. Legal experts argue that the firm should have known about possible safety issues. 

The Company Obtained Device Approval Via The 510(k) Fast-Track Process

Most medical devices must undergo the complete FDA approval process. However, these devices did not. Instead, Exactech used the 510(k) fast-track approval method. This allows medical device companies with limited safety results to claim their devices to others the FDA already approved. 

Symptoms Of Defective Exactech Knee Replacement

People with a defective knee implant may need revision or replacement surgery. If you have the following symptoms, talk to your doctor and an attorney: 

• Swelling of the ankle or knee: Your body may react to the problem joint by producing more fluid that can lead to severe swelling. 
• Pain: You may have severe pain in the joint that makes it difficult to walk. 
• Knee instability: If you feel like the knee gives out, you could need revision surgery. 
• Grinding: You may hear a grinding noise when you move your knee, which suggests the device is loose. 

Do You Have Pain From An Exactech Knee Replacement? 

If you have complications and pain from a defective device, follow these steps: 

• Gather records: Collect all medical records related to the device implant. You should find all documents related to the surgery and any follow-up procedures. Also, collect work records about time you missed. 
• Listen to your doctor: It is unlikely that medical professionals had reasons to worry about the devices until Exactech sent letters about the recall. Nevertheless, you should listen to your doctor’s advice, including whether you need replacement surgery. 
• Talk to a medical device lawsuit attorney: If you have a claim against the company, set up a free consultation with The Cartwright Firm, Inc. We have experienced attorneys handling many medical device recall claims and can tell you if there is a case. 

Talk To A San Francisco Exactech Knee Replacement Lawyer

If you have a defective Exactech knee replacement, you could be entitled to compensation in a lawsuit. Our Exactech knee replacement attorneys can help, so contact us today. 

Do you have an Exactech knee replacement? In February 2022, Exactech issued a recall for hundreds of thousands of ankle and knee replacement devices that were implanted between 2004-2022. 

These medical devices lacked enough packaging to protect them from oxygen before they were implanted. Oxidation causes the artificial joints to degrade over months and years. As a result, many patients with Exactech knee replacements are left with severe pain and may need revision surgery. 

The Cartwright Law Firm, Inc. has years of experience and impressive results handling knee implant clients. Learn more about Exactech knee replacement lawsuits, then contact us with questions. 

About Exactech

Exactech is a large medical device firm that makes artificial knees, hips, ankles, and other devices. The business also manufactures arthroplasty inserts for many knee replacements. 

The knee replacement made by Exactech is used in thousands of knee surgeries annually. The procedure is called total knee arthroplasty or TKA. A complete knee replacement uses a device to replace the damaged joint entirely. 

However, TKA is usually appropriate for treating chronic knee pain and arthritis. TKA also can be used to improve knee deformities and trauma. Unfortunately, the company has several implant replacement systems that have been recalled. 

In early 2022, Exactech issued a medical device correction that addressed their previous device recall. The recall involves all knee and ankle arthroplasty inserts that were placed in non-conforming vacuum bags. As a result, the FDA classified this recall as Class II. 

Why Was There An Exactech Knee Replacement Recall? 

The recall for these devices was because of a packaging failure. It’s critical for the devices not to contact oxygen before they are implanted. For example, these devices should be carefully packaged to avoid oxygen contamination while being shipped or stored. 

The layers of packaging for the knee inserts were determined to have allowed oxygen contact before they were inserted. The result was oxidation and rapid wear. The inserts that were shipped in the last eight years were in vacuum bags that are oxygen resistant. However, Exactech did not include a barrier layer with ethylene vinyl alcohol that enhances oxygen resistance. 

Many recipients of Exactech knee replacements received a letter about the recall. What should they do to learn if the recall affects them? Our product defect attorneys at The Cartwright Law Firm, Inc. can help you find out if you are affected by this recall. 

Exactech Knee Implant Complications

Exposure of the device to oxygen before it is implanted leads to oxidation. Plastic in the device can wear faster or even become damaged. The oxidation process may lead to premature joint failure. Some symptoms Exactech patients have endured include: 

• Swelling of the knee
• Severe pain while walking
• Difficulty putting weight on the affected limb
• Clicking or grinding in the device
• Knee instability
• Nerve damage 
• Device loosening

Sadly, premature wear in the joint can necessitate follow-up surgery to correct or replace the device. This may mean you must have another major procedure requiring months of painful recovery. If this happens, you could be entitled to compensation in a knee replacement lawsuit. 

Essential Facts About Exactech Knee Replacements

If you think this recall affects you, below are more essential details to know: 

Exactech Recalled Every Optetrak And Truliant Knee Replacement Implanted Since 2004

The knee replacement recall is for all Opetrak, Optetrak Log, and Truliant knee replacements sold from 2004-2022. So, at least 150,000 of the devices are under recall. If you have had one of these devices implanted in the last 18 years, you should check with your surgeon to find out if you need another surgery. 

Exactech Started Recalls in 2021

Exactech recalled Optetrak, Optetrak Logic, and Truliant devices in 2022, but a smaller recall started in 2021. The first recall was only for devices with five or more years of shelf life.

 However, the recall now covers all knee replacements, including devices put in patients and those still sitting on shelves at the hospital. 

Exactech Knew About The Problems

FDA started to receive adverse event reports about the devices in 2017. Legal experts argue that the firm should have known about possible safety issues. 

The Company Obtained Device Approval Via The 510(k) Fast-Track Process

Most medical devices must undergo the complete FDA approval process. However, these devices did not. Instead, Exactech used the 510(k) fast-track approval method. This allows medical device companies with limited safety results to claim their devices to others the FDA already approved. 

Symptoms Of Defective Exactech Knee Replacement

People with a defective knee implant may need revision or replacement surgery. If you have the following symptoms, talk to your doctor and an attorney: 

• Swelling of the ankle or knee: Your body may react to the problem joint by producing more fluid that can lead to severe swelling. 
• Pain: You may have severe pain in the joint that makes it difficult to walk. 
• Knee instability: If you feel like the knee gives out, you could need revision surgery. 
• Grinding: You may hear a grinding noise when you move your knee, which suggests the device is loose. 

Do You Have Pain From An Exactech Knee Replacement? 

If you have complications and pain from a defective device, follow these steps: 

• Gather records: Collect all medical records related to the device implant. You should find all documents related to the surgery and any follow-up procedures. Also, collect work records about time you missed. 
• Listen to your doctor: It is unlikely that medical professionals had reasons to worry about the devices until Exactech sent letters about the recall. Nevertheless, you should listen to your doctor’s advice, including whether you need replacement surgery. 
• Talk to a medical device lawsuit attorney: If you have a claim against the company, set up a free consultation with The Cartwright Firm, Inc. We have experienced attorneys handling many medical device recall claims and can tell you if there is a case. 

Talk To A San Francisco Exactech Knee Replacement Lawyer

If you have a defective Exactech knee replacement, you could be entitled to compensation in a lawsuit. Our Exactech knee replacement attorneys can help, so contact us today. 

Our successful case results are a reflection of the values and virtues we believe in and uphold at Cartwright Law Firm. Nothing stops us from pursuing justice on behalf of those who need it.

Robert E. Cartwright Jr.
Founder and Managing Partner