Exactech Recall Lawsuit
ExacTech, a company that produces implants and surgical devices, has announced a recall of some joint replacement systems due to premature wear and tear. The system has been linked to corrosion and metal debris in the joint, which can cause pain and complications.
Patients who have had problems with their ankle and knee replacements should consult their doctor immediately to discuss options. There may be potential risks associated with the ExacTech ankle or knee device.
Are you experiencing pain or needed ankle or knee revision surgery? The personal injury attorneys at Rosenfeld Injury Lawyers, LLC, are legal advocates for patients hurt by defective medical devices and malpractice.
Call our defective medical device lawyers at (888) 424-5757 (toll-free phone number) or use the contact form today for immediate legal advice and schedule a free consultation. All confidential or sensitive information you share with our legal team remains private through an attorney-client relationship.
ExacTech Knee / Ankle Medical Device Manufacturers
ExacTech is a medical device company that manufactures artificial hips, knees, and other orthopedic implants. The company also makes ankle arthroplasty polyethylene inserts used in knee replacements.
A total knee replacement system is a device implanted to replace a damaged knee joint. The damage can be due to arthritis, wear and tear, or injury.
Early in 2022, the company issued a medical device correction that expanded the previous recall of their OPTETRAK Comprehensive Knee System. The recall includes all ankle and knee arthroplasty polyethylene inserts packaged in non-conforming vacuum bags.
ExacTech said the recall was because the packaging was not per the required specifications. The defect could injure the patients and make knee revision surgery necessary.
The US Food and Drug Administration classifies the ExacTech recall as a Class II recall. Using the devices may cause temporary or medically reversible adverse health consequences.
If you or a loved one has had artificial hip, knee, or ankle surgery since 2010 and experienced complications, you may be eligible to file an ExacTech recall lawsuit. You may be able to recover compensation for your injuries, medical bills, and other damages.
What Is Knee Replacement Surgery?
In this surgery, the surgeon will remove the damaged parts of your knee joint and replace them with an artificial joint. This surgery is also called knee arthroplasty.
The main goal is to relieve pain and improve joint function. Knee replacement surgery is usually performed under general anesthesia. It takes about two to four hours, but most people have to stay in the hospital for three to five days after surgery.
However, any ankle or knee replacement procedure that goes wrong due to medical malpractice or a defective knee replacement unit, such as the ExacTech knee replacement insert will likely require knee revision surgery.
A knee revision surgery helps relieve pain but also has a higher risk of complications. Moreover, a revision surgery comes with added medical expenses.
What Is a Knee Replacement Device?
A knee replacement device, also called a knee prosthesis, is a surgically implanted device. It replaces the weight-bearing surfaces of the knee joint to relieve pain and disability.
Doctors choose this option when other treatments such as physical therapy, medication, and weight loss have failed to provide relief.
Knee replacement involves replacing the damaged or worn-out surfaces of the knee with artificial parts, called implants. The three main types of devices are:
- Total Knee Replacement (TKR): In this procedure, doctors replace both the shinbone (tibia) and kneecap (patella) with metal implants. Surgeons place a plastic spacer between these two new metal surfaces to create a smooth gliding surface.
- Partial Knee Replacement (PKR): In this procedure, doctors only replace the damaged portion of the knee with a metal implant. The healthy bone and cartilage are left intact.
- Unicondylar Knee Replacement (UKR): It is also known as a partial knee replacement. In this procedure, only the damaged compartment of the knee is replaced. However, the incision is smaller than that of a TKR.
The ExacTech knee replacement implant is an example of a knee replacement device, made of metal and plastic. It is a total knee replacement unit used in knee surgery for patients with arthritis or other conditions that cause damage to the knee joint.
The recent ExacTech recall lawsuits were filed due to the defective nature of some ExacTech knee replacement systems. As a result, many patients had to undergo corrective revision surgery to fix the damage caused by an ExacTech implant.
In an ExacTech knee implant lawsuit, the patient can seek compensation for the economic and non-economic damages caused by the ExacTech implant. The same applies to ankle replacement surgeries involving ExacTech replacement systems.
Which Ankle and Knee Replacement Devices Are Part of This Recall?
ExacTech products could be used in knee or ankle replacement surgery. However, the company has recalled some products due to non-compliant packaging. The following devices are a part of the ExacTech recall:
- Optetrak® All-polyethylene CR Tibial Components
- Optetrak® All-polyethylene PS Tibial Components
- Optetrak® CR Tibial Inserts
- Optetrak® CR Slope Tibial Inserts
- Optetrak Logic® CRC Tibial Inserts
- Optetrak Logic® PS Tibial Inserts
- Optetrak Logic® PSC Tibial Inserts
- Optetrak Logic® CC Tibial Inserts
- Optetrak® PS Tibial Inserts
- Optetrak® HI-FLEX® PS Tibial Inserts
- Optetrak Logic® CR Tibial Inserts
- Optetrak Logic® CR Slope Tibial Inserts
- Truliant® CRC Tibial Inserts
- Truliant® PS Tibial Inserts
- Truliant® PSC Tibial Inserts
- Truliant® CR Tibial Inserts
- Truliant® CR Slope Tibial Inserts
- Vantage® Fixed-Bearing Liner Component
Nearly 60,000 OPTETRAK® and OPTETRAK Logic® units have been implanted in patients since 2014. Meanwhile, 25,000 TRULIANT® units have been inserted in patients needing knee and ankle replacement.
If unsure which insert was used in your knee replacement procedure, you should talk to your physician or surgeon. They will have this information in your medical records.
Recalled Hip Replacement Units
Besides knee and ankle implants, ExacTech has also recalled many hip replacement units. The ExacTech Connect GXL liners are used with the company's G2 metal-on-metal hip prosthesis and have been linked to severe complications.
The FDA has received reports of metallosis, tissue damage, and device failure in patients who have received these hip implants. This recalled ExacTech hip replacement unit is used in the following medical devices:
- ExacTech Acumatch®
- ExacTech MCS®
- ExacTech Novation®
ExacTech has asked hospitals to return these hip replacement devices to the company and not use them in any hip replacement surgery. People who already have these ExacTech hip replacement units in their bodies may undergo corrective surgery to remove and replace the device.
A revision can be a painful and complicated surgery with a long recovery time. If you or a loved one has received an ExacTech hip replacement unit, you should contact a lawyer to discuss your legal options.
You can file a hip replacement lawsuit, claiming compensation for medical expenses and other losses caused due to the company's hip replacement devices. Until now, many patients have filed ExacTech recall lawsuits against the company.
What Problems Are Associated With the Recalled Devices?
First, it's essential to understand how these implants are made. An average knee replacement insert has these parts:
The femoral component is the part that goes into your thighbone or upper leg. It's made of metal alloys, plastics, and ceramics.
Tibial Tray Component
The tibial tray component is the part that goes into your shinbone or lower leg. Like the femoral component, it comprises different metals, plastics, and ceramics.
Patellar Button Component
The patellar button component is the part that goes into your kneecap or patella. In most cases, this component is made of metal alloys or plastics.
Polyethylene Insert Component
The polyethylene component is a plastic insert between the tibial tray and the femoral component. It cushions the knee joint.
When a knee or ankle replacement unit is implanted, the surgeon first makes an incision in your leg to reach the bones that need replacement.
Once they access your bones, they'll remove any damaged cartilage and bone. Next, they'll shape the bones to fit the latest components. Finally, once the bones are ready, they'll insert the new components and secure them in place with either screws or cement.
After that, they'll close up the incision with stitches or staples. In some cases, they may use a drain to prevent fluid buildup.
Recalled Knee and Ankle Replacement Problems
The affected ExacTech knee and ankle replacements were not made according to the design specifications. In addition, the incorrect packaging led to vacuum sealing defects. As a result, the devices may not have undergone adequate sterilization.
In particular, the knee or ankle implant could get damaged during transport and cause serious patient injuries. Such an ankle implant could cause:
Patients may need to undergo revision surgery to replace or repair a failed joint replacement. Since ExacTech knee and ankle replacement units can cause serious problems, affectees can file an ExacTech recall lawsuit.
Symptoms of a Defective Ankle or Knee Replacement Systems
People who have defective ankle or knee replacement systems in their bodies will experience specific symptoms that could mandate revision surgery. After the ExacTech recall, your surgeon will likely contact you. However, you shouldn't wait to hear from them if you already have the following symptoms:
Doctors usually place joint replacements in areas with a lot of fluid. Your body's natural reaction to the presence of a foreign object is to try and flush it out with extra fluid. It can cause significant ankle swelling, which may or may not be accompanied by pain.
Most patients with recalled ExacTech implants experience pain in the joint area, although this isn't always the case. The pain can range from a dull ache to sharp and debilitating. It may be constant or intermittent and get worse with activity.
Do you feel like your ankle or knee is "giving out" on you? A loosening of the implant often causes such a feeling. If you have this symptom, you should see your doctor right away.
As an implant loosens, it becomes completely detached from the bone. As a result, it can lead to instability, pain, and swelling.
Inability to Bear Weight
Joint replacement surgeries allow patients to bear weight on the affected joint again. However, if your ankle or knee replacement is defective, you may find it difficult to put any weight on it.
A defective ExacTech medical device in your knee or ankle may make a grinding noise when you move it. The noise is usually a sign that the implant is loose.
See your doctor immediately if you have any of these symptoms. You may need to have your ankle or knee replacement system replaced. In most cases, the solution is corrective surgery.
What Should a Patient With a Recalled ExacTech Ankle or Knee Implant Do?
ExacTech has told surgeons not to insert an ExacTech implant joint replacement unit in any patient. Any hospitals or surgeons possessing the recalled implants should return them to ExacTech.
If you had, or are scheduled to have, surgery to insert an ExacTech ankle replacement unit, you should speak with your surgeon about the recall. You may also want to consider seeking a second opinion from another surgeon about ExacTech implants.
If you already had surgery to insert an ExacTech implant, your doctor should monitor you for any signs of insert failure. ExacTech has advised doctors to monitor patients and look for the following symptoms:
- Swelling or grinding joint noise
- Inability to bear weight
- Instability of the ankle or knee
If the doctor suspects a failed device, they should order an MRI or X-Ray to check for metal corrosion. If the device is confirmed to have failed, you will likely need corrective revision surgery to remove and replace the implant.
It is vital to note that not all patients who have received a recalled device will experience problems. However, if you are experiencing any of the above symptoms due to knee implant failure, you should talk to your healthcare provider.
If you do not have any of these symptoms, there's no need for preemptive surgery to remove the medical device. Only people with defective ExacTech implants should be scheduled for surgery, especially if they experience a lack of mobility and pain.
Who Can File an ExacTech Recall Lawsuit?
You can file an ExacTech recall lawsuit if you or a loved one had an ExacTech knee implant with defective packaging and the insertion caused severe side effects or required revision surgery.
The ExacTech knee replacement lawsuit would seek compensation for your medical bills, lost wages, and pain and suffering.
If you have already had revision surgery to remove the ExacTech knee implant, you may still file an ExacTech knee replacement lawsuit seeking compensation for your costs.
You may also join an existing class-action ExacTech lawsuit against the manufacturer.
What Compensation Can Victims of Defective ExacTech Knee and Ankle Replacement Units Receive?
Defective ExacTech knee, ankle, or hip replacement units can lead to severe injuries and complications. You may be eligible for compensation if you or a loved one has been affected by a defective ExacTech knee, ankle, or hip replacement unit.
Premature wear of the ankle arthroplasty polyethylene inserts can lead to the need for revision surgery. It can be costly, and victims may face mounting medical bills.
In such case, you can receive compensation for out-of-pocket expenses related to your injury, including:
- Medical costs
- Physical therapy
- Assistive devices
Pain and Suffering
You may also be eligible for pain and suffering damages. These are non-economic damages intended to compensate you for the physical pain and emotional suffering you have endured.
In some cases, victims of defective ExacTech knee devices may also be able to recover punitive damages.
Jurors award punitive damages in cases where the at-fault party acted with gross negligence or malice. Punitive damages are intended to punish the at-fault party and deter similar behavior in the future.
An experienced attorney can help you understand your legal rights and options. Whether you received a recalled ExacTech device for a total hip replacement or total joint replacement, you need to talk to your doctor immediately.
ExacTech provided orthopedic surgeons with monitoring guidelines for the recalled devices. A failed implant can cause several problems, such as bone loss and loosening joints.
Besides bone loss, defective medical devices from ExacTech can also lower your range of mobility and cause excruciating pain in the thigh bone and hip regions, especially in cases of total joint replacement.
Many recalled ExacTech systems are causing side effects. If you have been affected, consult your doctors and personal injury lawyers to get all the information you need for a lawsuit.
Seek Legal Counsel for Hip, Knee, Ankle Device Lawsuits
Knee replacements are common in the elderly with arthritis or similar conditions. Likewise, hip replacements are required due to old age or severe falls.
Are you or a loved one a victim of a defective knee, ankle, or hip replacement device? You can take legal action by filing an ExacTech lawsuit to ensure you get compensated for your losses.
Whether you've had a total ankle replacement or partial knee replacement surgery, ask your doctor if they used ExacTech knee implants or ankle replacement units. If they used a recalled device in your surgery and experienced side effects, you could file a knee, ankle, or hip replacement lawsuit.
Not many personal injury cases have been filed against ExacTech for the recalled devices used in the ankle, knee, and hip replacements. Thus, there's no class action ExacTech lawsuit at the moment. On top of that, not enough new claims are filed because most patients are unaware of the recall.
Hire a Product Liability Lawyer to Resolve Your Defective Medical Implant Compensation Claim
Many patients are filing ExacTech knee and ankle lawsuits seeking financial compensation for damages caused by the replacement device manufacturer. Call the personal injury attorneys at Rosenfeld Injury Lawyers, LLC to schedule a free consultation to discuss your claim.
We accept every hip, ankle, and knee replacement lawsuit through a contingency fee agreement. This arrangement ensures you pay nothing until we resolve your ExacTech lawsuit through a negotiated settlement or jury verdict.