In August 2021, Exactech recalled some of its knee and ankle implants due to early wear and degradation of the polyethylene liners in the joint replacements. But in February 2022, the Exactech recall expanded to include all ankle and knee implants manufactured in 2004 or later. Over 147,000 of these medical devices have been implanted in patients across the U.S.
The impact of Exactech’s defective polyethylene liners used in its many joint implants is proving to have widespread effects. Exactech lawsuits have been filed against the company for not only the knee and ankle implants but also hip implants that have worn down far earlier than they should. These degraded joint replacements have caused some patients to suffer a wide range of symptoms. Some have even required complex revision surgeries to replace the implant, and many more may need this surgery in the future.
While Exactech has introduced a claims program to cover medical costs caused by their recalled products, other damages, like pain and suffering, are not included in their compensation. And there’s no guarantee of full reimbursement or what options those who have already undergone knee, ankle, or hip revision surgery have.
To ensure adequate compensation, patients with a recalled Exactech knee, ankle, or hip joint replacement should consult a product liability attorney before submitting a claim with the company. An attorney can review your case and discuss your legal options.
Why Are Exactech Joint Replacements Recalled?
Exactech knee, hip and ankle joint replacements have several components, including a polyethylene liner that acts as cartilage to absorb the impact of movement. A packaging issue allowed too much oxygen to reach the polyethylene liners used in the implants. The packaging defect has led to premature wear and degradation for many patients with a recalled implant, causing them to endure risky revision surgeries that require even more time to recover from than the initial joint replacement.
While only a Class II recall, revision surgery is serious, and the increased risk of early Exactech device failure means more patients may experience future complications and require surgery. As a result, many affected by the Exactech recall have filed product liability lawsuits against the company. A greater influx of Exactech lawsuits is expected as patients become aware of the issue.
Warning Signs & Injuries Caused by Exactech Implants
There are several warning signs of early wear and degradation of an Exactech hip, ankle, or knee joint replacement. Pain and swelling, instability and mobility issues, difficulty bearing weight, stiffness, and a grinding noise are all symptoms of a defective polyethylene liner.
Beyond the pain and mobility limitations, the injuries caused by recalled Exactech implants include:
- Bone loss (osteolysis)
- Severe pain
Unfortunately, symptoms of bone loss, like pain and swelling, don’t present until the damage has already occurred. These and other symptoms and injuries from a failed Exactech joint replacement can be extensive. It may affect a person’s ability to perform job duties, enjoy life, and participate in everyday activities.
Issues of Early Joint Implant Failure and the Dangers of Revision Surgery
A knee, ankle, or hip replacement will often last for the rest of the patient’s life. This is the ideal situation for any joint replacement because of the risks, complications, and recovery time of revision surgery. Most implants last at least 10-20 years, but some last 30 or more.
Joint replacements provide pain relief, increase mobility and function, and relieve pressure on other joints in the body. But if a device fails, the ramifications can be severe. Patients with a recalled Exactech implant need to be examined and monitored to see if there’s an issue with part of the device, like the polyethylene liner, and whether bone loss or other damage has occurred. Surgery may be needed if the Exactech device has failed.
However, there are clear risks of revision surgery and significant implications for the patient. The surgery length and process are more complicated, and there are increased health risks. The recovery and rehabilitation time and high medical and personal costs also have a serious effect.
Risks & Complications of Revision Surgery
Health Risks. Every joint replacement surgery has risks, and since it’s longer and more complex than the first joint replacement, there are greater risks of complications. These surgical risks include infection, blood clots, blood loss, nerve damage, bone fractures, stroke, heart attack, and lung complications.
There are also post-operative risks to the heart and lungs, and the outcomes of revision joint surgery could be less positive; it may not restore a patient’s range of motion as well as the initial surgery and cause increased pain and inflammation. Some studies even suggest those who undergo revision surgery are at an increased risk of more revisions in the future. With almost 150,000 recalled Exactech joint replacements implanted, there could be a devastating effect on thousands of Americans.
Recovery & Rehabilitation. The type of care after the first and second joint replacement surgery is typically the same, but revision surgery takes longer to heal from. Recovery to the point of normal function after revision surgery varies depending on the joint and damage to the surrounding area, health of the patient, and post-op care.
It’s not uncommon for patients who have revision hip surgery to take 12-18 months to recover fully, whereas the initial surgery takes around 6-12 months. It could take up to 12 months to fully recover from revision knee replacement surgery, compared to as little as 3-6 months after the first surgery. This means that patients that need a replacement for a failed Exactech implant will have to endure a painful and lengthy recovery earlier than they should have.
Complex and Lengthy Surgery. Revision surgery is more complex than an initial joint replacement. Sometimes, multiple surgeries are needed depending on what the surgeon has to do. The whole implant might need to be removed, while others simply need to be fixed or have a part replaced.
But revision joint surgery may also require the surgeon to fix any damage done to the bone and surrounding area, like a bone graft. The surgeon may have difficulty detaching part of the implant, and sometimes an artificial component must be implanted if the damage is too great. All of this lengthens the surgery, increasing health risks and costs. But many patients with Exactech knee, hip, or ankle implants have no alternative and must undergo another surgery because of a failed Exactech joint replacement.
High Costs. Surgery is expensive, and those who need revision surgery are stuck with high medical costs in a short timeframe. Rehabilitation, hospital stays, medications, medical imaging and appointments with doctors and specialists are costly. If uninsured, the cost of a total hip replacement could be anywhere from $20,000 to $100,000. Even those with insurance typically have a deductible that’s a few thousand dollars.
It also takes more time to recover from revision surgery – a year and a half for hip implants – which may affect the patient’s ability to perform their job. Some are unable to work for long periods of time, adding to the financial impact.
Another cost that many underestimate is the emotional and mental impact of surgery. Being able to take care of children and a home and enjoy activities when exhausted and in pain is extremely difficult. The financial, mental, and emotional struggles caused by revision surgery matters, and compensation for a recalled Exactech implant should consider all of these factors.
What to Do if Your Exactech Joint Replacement is Recalled
If you have an Exactech knee, hip, or ankle implant, check the list of recalled joint replacements. You’ll need your device’s serial number, which will be noted in your medical records. Patients that have warning signs or symptoms of a failed device should contact their doctor immediately. But even if you aren’t experiencing symptoms, your doctor should monitor you because of the increased risk of early wear to the polyethylene liner.
Unfortunately, Exactech has failed to notify most patients of the recall, leaving them unaware of the health risks and complications that may occur (or have already occurred). The company has placed much of the burden of notifying patients on doctors and needs to be held accountable.
If your Exactech joint replacement is recalled, you may be able to seek compensation for not only medical costs but other damages. However, do not file a claim with Exactech before contacting a product liability attorney. The company is only offering reimbursement of medical fees, and filing a claim with them may negatively impact – even prevent – you from filing a lawsuit in the future.
Revision joint surgery caused by a faulty medical device has risks, is costly, and may lead to serious complications. You deserve to be adequately compensated. Lawsuits against Exactech have already been filed, and many more are expected. Contact a product liability lawyer to discuss your legal options today.