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To many people who may struggle with ongoing issues in their joints, joint replacement surgery can offer hope for pain relief and improved mobility. About 650,000 knee joint replacements are performed in the U.S. each year. Joint replacements generally tend to be successful, allowing most people who have them to return to active lives free from chronic pain. Unfortunately, this isn’t always the case when joint replacements fail.
The personal injury lawyers at The Carlson Law Firm are actively investigating the Exactech recall to determine the options for those affected by the recalled knee and ankle devices.
What are Common Reasons for Joint Replacement Failure?
Typically, most implants should last about 20 years or longer. However, some may fail sooner or at higher-than-expected rates because of defects in the design or packaging. For example, recently there has been a sweeping recall for the Exactech knee and ankle replacement systems after it was discovered that they contained a defect that causes them to fail prematurely. This recall has affected more than 147,000 knee implants and ankle implants placed in American bodies since 2004—leading to thousands of patients suing the manufacturer.
The company expanded its recall to include “all knee and ankle arthroplasty polyethylene inserts packages in non-conforming bags regardless of label or shelf life”, according to Exactech’s recall notification.
In addition to defects, those suffering from joint replacement pain may be the result of the following reasons:
Wear and Loosening
When first laced, the well-functioned joint replacement needs to be firmly fixed to the bone. However, over time, the joint wears out due to normal wear or improper use of the implant. This leads to the plastic implant breaking down and particles can be released, causing the body to digest the bone.
Although infection is a risk with any surgical procedure, in joint replacement surgery, a metal or plastic implant can serve as a surface for bacteria to grow and accumulate. For lack of better words, bacteria love these metal and plastic implants and are detrimental to the patient as their immune system cannot effectively clear them out on these surfaces. If diagnosed, joint replacement infections almost always need surgery.
Instability happens when the soft tissue structures around the joint are unable to provide enough stability to support the joint and allow full function. Dislocations may be treated with a period of immobilization, but sometimes may need revision surgery. Sometimes physical therapy and bracing can fix the issue, but other times surgery may be required.
Stiffness occurs when there is a loss of range of motion in the joints, most commonly found in the shoulder and knee. The positioning of the implants during surgery is critical because if there is stiffness throughout the surgery, they often get worse when taking into account the patient’s pain adds to the stiffness.
After a knee or hip joint replacement, the prosthetic joint will be connected to your surrounding bones. A fracture in one of these bones may cause your new joint to loosen or get damaged.
What was the Problem with Exactech?
Exactech is a global medical device company that specializes in surgical implant systems for use in joint replacement surgeries. In August 2021, Exactech initiated a nationwide recall of all its knee replacement and ankle replacement implant systems. The recall was initiated after Exactech discovered that a defect in the vacuum-seal packaging of its knee replacement systems was causing the polyethylene insert component to oxidize before use.
Potential problems caused by Exactech recalled knee and ankle implants include:
- Accelerated wear
- Debris production
- Bone loss
- Component fatigue
- Component cracking or fracture that will require surgery to correct
These problems are causing patients across the United States to experience painful complications, often resulting in the need for revision surgery, continuing medical care, and other damages caused by these defective and unreasonably dangerous implants. For those patients with compromised health, additional surgery may raise significant health risks.
What Knee and Ankle Replacements are Part of the Exactech Recall?
The defective components affected by the Exactech recall include the following:
- OPTETRAK® All-polyethylene Tibial Components
- OPTETRAK® Tibial Inserts
- OPTETRAK Logic® Tibial Inserts
- TRULIANT® Tibial Inserts
- VANTAGE® Fixed-Bearing Liner Component
If you are unsure if you received the affected component during your surgery, you should contact your physician, if they haven’t already, who will check the serial number of your component against the list of affected devices provided by Exactech.
In addition, you can look up your knee or ankle implant’s never on Exactech’s website which can be found in your medical records. Individuals also may never receive an Exactech recall notice if they have already had the recalled Exactech implant removed or undergone revision surgery after their joint failed.
What are the Symptoms of an Exactech Knee or Ankle Failure?
Although your surgeon should get in contact with you in regards to your joint replacement, you should be concerned if you experience the following:
- New or worsening ankle swelling
- New or worsening knee swelling
- Pain while walking
- Grinding or other noise in the knee or ankle
- Inability to bear weight
- Clicking on your knee or ankle
What is Exactech Offering for the Recent Recall?
Exactech may tell you that they will cover your out-of-pocket medical expenses. If you are still unsure as to what your legal rights look like, contact our office today to schedule a free consultation to discuss with one of our legal experts before signing or agreeing to any compensation from Exactech.
Here at The Carlson Law Firm, We Can Help
If you or someone you know had an Exactech knee and ankle device implanted which wasn’t packaged correctly, the device may begin to break down much earlier than expected. More specifically, the plastic portion of the device may begin to degrade and may need corrective surgery. If you would like more information regarding your legal rights, contact our office today.
We care, we can help.