Exactech Knee and Ankle Implant Recall Attorneys
Medical device maker Exactech has issued a recall for tens of thousands of plastic inserts used in knee and ankle replacements because the parts are prone to premature wear and can lead to implant failure.
Individuals who have had an Exactech knee or ankle replacement surgically implanted and have experienced an early failure may be able to file a claim against Exactech.
The medical device attorneys at Jeffrey Glassman Injury Lawyers are currently monitoring the recall and accepting clients who have been affected. Our attorneys believe that patients who suffered complications linked to an Exactech knee or ankle replacement have a strong likelihood of winning large settlements. It is not unusual for defective medical device cases to result in settlements or verdicts in the multimillion-dollar range.
Medical device manufacturers such as Exactech are legally obligated to ensure that their products are safe and function as intended. The company's recall announcement admits that all of the recalled knee and ankle replacement parts are prone to defect and experienced a high failure rate.
Contact our Boston law office today for a free legal consultation. There are no fees until we win your case and obtain compensation for you.Defective Packaging at the Root of Early Exactech Implant Failures
The recall is for Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Inserts. These plastic inserts are placed between metal components in knee and ankle replacements to cushion a person's joints.
The recall applies to tibial inserts and liner parts from these Exactech knee and ankle replacement systems:
- Optetrak Logic
In an Urgent Medical Device Correction letter sent to surgeons on Feb. 7, 2022, Exactech explains that it recalled the devices because of vacuum packaging that failed to protect the inserts from oxygen exposure. Over time, oxygen exposure can cause the inserts to degrade and lead to early device failure.
This packaging defect will be at the heart of all Exactech knee and ankle replacement claims.
The recall applies to all of the company's knee and ankle inserts packaged in something known as "out-of-specification" bags, "regardless of label or shelf life."
According to Exactech, inserts manufactured beginning in 2004 were packaged in the bags, and nearly 150,000 of them have been implanted in patients in the United States since then.What Should i Do if My Exactech Knee or Ankle Implant Has Been Recalled?
If you have an Exactech knee or ankle implant that is affected by the recall, you should contact your physician, especially if you are experiencing any of these problems:
- New or worsening swelling
- Pain while walking
- Inability to bear weight
- Grinding or other noise
- New symptoms of clicking
If you are unsure whether you have one of the recalled implants, you should contact your surgeon to find out.
Your surgeon may reach out to you to verify that your implant is working correctly and order X-rays if a failed implant is suspected.
Exactech does not recommend surgery for individuals who are not experiencing pain or those having other difficulties such as problems walking. The company said patients, in tandem with their doctors, should make decisions about removing or exchanging the devices. Physicians should explain the benefits and risks of all treatment options with their patients.
The U.S. Food and Drug Administration categorized the recall as a Class 2 recall because the affected knee and ankle replacement parts can cause temporary or medically reversible health issues. You can read the FDA's recall information here.
On its recall website, Exactech details a process for patients with defective implants to submit a claim and obtain reimbursement for out-of-pocket expenses related to the implants. However, our personal injury attorneys want you to understand that patients who opt to file reimbursement claims with Exactech may forfeit their rights to bring an action against the company.
Patients who require corrective revision surgery because of Exactech's problematic implants may be able to file a product liability lawsuit against the manufacturer and seek monetary damages, including damages for pain and suffering, medical expenses, lost wages, and more.
For that reason, you should speak with a lawyer before agreeing to a settlement with the device maker. You do not want to waive your right to a payout from the Exactech recall.
After reviewing the facts of your case, an attorney can advise as to whether you have a viable claim against Exactech. You have limited time to act after you have suffered harm from a medical device. For that reason, it is in your best interest to avoid any delays and obtain the help you need to protect your legal rights.Recalled Exactech Knee and Ankle Implants Can Cause Bone Loss
Exactech's recalled knee and ankle implants can cause a slew of potential health problems, including:
- Accelerated wear
- Debris production
- Bone loss
- Component fatigue
- Component cracking
- Component fracture
These complications are serious and can require revision surgery to fix.
As with all surgical procedures, there are risks connected to revision surgery. Revision surgery comes with a greater risk of complications because it takes longer and is more complicated than the initial surgery.
According to the American Academy of Orthopaedic Surgeons, the potential complications of revision knee surgery include:
- Wound infection and poor wound healing
- Stiffness in the knee or reduced range of motion
- Blood clots in the legs, which can travel to the lungs and result in a pulmonary embolism
- Bone fracture during surgery
- Damage to nerves and blood vessels
- Heart attack, stroke, and other severe and life-threatening medical problems
In the worst-case scenario, complications may be so severe that the patient does not survive the surgery.Problems With Exactech's Optetrak Knee Implant
Although Exactech said its packaging issues began in 2004, its Optetrak knee system has been available since 1992. According to Exactech's recall letter, data extracted from other countries show that the implant has much higher overall revision rates when compared to other knee implants.
This is not the first time Exactech has been in hot water over one of its products. In 2017, the company faced numerous lawsuits over the Optetrak knee implants. Patients claimed that the implants failed early and caused instability and the need for revision surgery. The suits said the medical device maker knew or should have known of the problems but did not warn consumers and continued to sell the defective implants.
Product liability suits against medical product manufacturers are not unusual. Device makers often ask the FDA to "fast track" their products to get to market quicker. While this strategy can benefit patients because they have access to medical products in a timelier manner, there is one major drawback. The quick turnaround means the devices go through less testing in most cases.
Due to the aging baby boomer population, joint replacement surgery is rising. Knee and hip replacements are the most commonly performed joint replacements. The National Institutes of Health estimates that orthopedic surgeons will perform almost 3.5 million knee replacement surgeries per year by 2030. People with arthritis, serious injuries, or wear-and-tear injuries often undergo knee replacements to alleviate pain.
If you or a family member is facing revision surgery following an Exactech knee or ankle replacement, contact the Boston medical device injury lawyers at Jeffrey Glassman Injury Lawyers at (617) 777-7777 for a free consultation or fill out our online form.