Exactech is a medical device company that makes implants for joint replacements. Unfortunately, the product packaging experienced some issues. As a result, the company initiated a voluntary recall of some of its implants in 2021.
One year later, the Exactech knee recall expanded to include even more orthopedic implants. In all, this recall impacts hundreds of thousands of devices. Here is what you need to know about the FDA’s recall reminder on Exactech knee implants.
The Problem With Defective Joint Implants
Aside from the fact that they are defective and do not work, defective joint implants are difficult and dangerous to remove. Surgery is necessary to take out and replace defective orthopedic implants, and surgery is dangerous.
Undergoing surgery is also debilitating. In this case, the removal of a faulty Exactech device could require six months or more of recovery.
Defective orthopedic implants — or any other medical implant — can also cause depression. Patients who get implants do so in the hope that certain health problems will disappear or lessen. But when the implant itself breaks or is defective, hope and despair can arise, especially if another surgery is needed.
In the FDA’s reminder of the Exactech knee recall, the agency states that people who do not experience negative symptoms will not need this surgery. However, those without symptoms are still at risk of an implant failing prematurely.
If surgery is necessary in your case, there are some stark realities you must understand. The first is that joint-replacement surgery is not routine. It is a risky procedure that has a higher chance of failure than the first procedure. This is not surprising, given that the surgeon must complete various complex tasks, including:
- Removing the old implant without harming the patient
- Removing bone, cement, and tissue
- Installing the replacement implant without causing damage
If the surgeon is successful, the patient may still experience chronic pain and some debilitation.
Exactech’s History With Joint Replacements
Long before the Exactech knee recall, the company had a lucrative history in the healthcare industry.
In 1985, it began operations with the mission of helping surgeons and patients by producing cutting-edge implants. And since its creation, Exactech has helped hundreds of thousands of patients regain mobility, range of motion, and some semblance of stability in their lives.
Although doctors often prefer less invasive treatments for their patients, some patients have no choice but to undergo surgery. Joint replacement is one of those times where the best option is the most intrusive.
During a joint implant surgery, the surgeon removes the patient’s damaged joint. They then prepare the site and implant a new, synthetic joint that should last anywhere between 10 to 25 years.
The Discovery of the Packaging Defect
For decades, Exactech has enjoyed great success with its products. In 2017, it sold to a buyer for over $725 million. However, a few years ago, the company realized that there was a problem with 80% of the countless implant products it had produced since 2004. The vacuum-seal packaging bags were missing a barrier layer.
This layer protects the implants from the outside air. Once Exactech products interact with the outside air for too long, they may begin to deteriorate. This is due to the deteriorating effect of oxidation.
Exactech implants have polyethylene linings. When these linings begin to oxidize, they prematurely wear down and eventually become useless or dangerous. Patients with compromised joint implants will eventually start to see signs that their implant is problematic. These may include:
- Reduced movement
- A rise in joint pain
- Difficulties bearing weight on the joint
- Grinding and clicking noises coming from the joint
If you have an Exactech joint and notice any of these symptoms, your implant may be failing. You should strongly consider seeking medical attention.
What Happens Next?
Exactech has established a claims process for out-of-pocket expenses. However, if you have a defective implant, your recourse may not be limited to this claims process. You may also be entitled to bring a claim for compensation for non-economic damages as well, such as pain and suffering, reduced quality of life, and emotional distress.
For this reason, it’s best to file a claim for the Exactech knee recall through an attorney. You may miss out on valuable compensation if you deal with the company directly.
Reach Out to a Qualified Attorney at The Joel Bieber Firm
Have questions or concerns related to the Exactech knee recall? If you have one of these implants, you may be eligible for compensation. A seasoned attorney from The Joel Bieber Firm can help you determine your best options. Contact us to learn more today.