Hi everybody. This is Arkady Frekhtman, a New York City personal injury trial attorney. And today, we’re talking about Exactech. On April 7th, 2022, my birthday, a company announced that there was a recall on Exactech knee replacements. And the reason for the recall was because there was a part, just one part, a component of the knee replacement system that was defective. And it was in fact dangerous. And that part was the cushion, the tibial insert.

So this is a knee, and you could see that the human knee has a cushion. Sometimes when you have arthroscopic surgery, there’s a meniscal tear. And so when you have your knee replaced, it gets replaced with either titanium, there are metal components in there, but one of the components is plastic and that is the cushion, the tibial insert. And what it does is it helps you walk with the knee replacement because it’s a load-bearing weight, right? It has to bear weight, that plastic piece.

So what happened was that piece was being stored improperly. The company that makes the Exactech system was storing that plastic piece in a bag that allowed oxygen to creep in. And when oxygen creeps into a storage bag that has these plastic tibial inserts, what happens is something that’s known as oxidation. And with oxidation, essentially, the simple way to explain it is just, with time, it just degrades and the plastic just breaks. And you do not want that happening when it’s inside your body. That is just a terrible, terrible, very, very scary thing.

So the company actually wrote a letter and you could find this online on their website if this affects you. And they said, “Dear valued patient…” First of all, they said, “Surgeon or facility letterhead.” I guess this is a letter that they wrote. And then they sent it to the doctor. And they said, this is on April 7th, “Dear valued patient, because the safety and health of our patients is our top priority, we are writing to inform you that between the years of 2004 and 2022, you received a specific type of partial or total knee replacement system manufactured by the orthopedic device company, Exactech, Inc. headquartered in Gainesville, Florida. And one component, the plastic tibial insert, has now been recalled.”

And then they explain all the reasons that it allows oxygen to seep into the bag. By the way, the proper way to do it is to have nitrogen, not oxygen, because you don’t want that oxidation, which will destroy the piece. So the interesting thing that I found from that sentence, is the first sentence, “Because safety and health is our top priority.” The interesting thing, I mean, as a trial lawyer, the thing that really hit me as soon as I read that sentence was like, wait a minute. They’re saying that that’s their top priority, right? The health and the safety of their patients. But yet they couldn’t figure out that this piece was being stored improperly from 2004, till 2022, for 18 years.

I mean, that’s a long time. That’s almost two decades. How do you not figure out that it’s being stored improperly? And there were 150,000 surgeries in the United States during that time. So I just don’t get it. I mean, that seems like almost warranting punitive damages. That seems like gross negligence, like very, very gross negligence. But I’ll have to do a little bit more research to figure out what was the reason for that for not figuring it out for that long.

And so basically, the plastic part can oxidize either on the shelf, which is the best scenario, right? Because if it oxidizes and then starts breaking apart, degrading on the shelf, so you just throw it out and put a new one on the shelf. But it could also degrade inside someone’s body. And that is very dangerous because if that happens, then it becomes toxic to the surrounding muscles, to the tissues, to the ligaments. And it could actually lead to osteonecrosis, which is bone death. So that could then lead to revision surgeries to fix the problem, but also possible if that plastic starts leaking, it could lead to poly wear disease. And then that could lead to a host of so many different complications.

So what Exactech did was they wrote this letter and they talked about some of the symptoms like swelling, difficulty walking, grinding, instability clicking, the inability to bear weight since it is a weight-bearing joint, the knee, and things like that. And they said, if you have that, they can do diagnostic testing and then perhaps see your orthopedic doctor, and then they would have some kind of subsequent treatment and corrective action.

So I thought this was interesting. I think we’re going to get involved with this litigation along with some partners that we work with because we work with larger firms that litigate mass tort cases, and this is a mass tort case all across the country. So we’re going to partner up with larger firms, including one here in New York City and we’re going to be handling Exactech cases.

So I thought this was just really interesting, but the thing that really hit me was that 18 years. How could it be that long until you figure out that the simple bag that you store the little plastic piece in is leaking oxygen? I mean, even when you buy coffee, you make sure that it’s sealed and then the coffee will stay fresh. And if you open it up, then you have to use it because otherwise, the coffee goes bad. Oxygen will ruin a lot of different things, just like salt water will ruin the boats and pieces. Oxidation is very dangerous and you definitely don’t want that happening inside a human body. That’s just beyond horrific.

So let us know if you have any questions or if you know anyone that had the Exactech component installed, the Exactech knee replacement, we’re happy to just give a free consultation. We have our cell phone number in the description. You can contact us and we’re here for you. Okay. Thank you so much. And we look forward to the next video. Have a great day, everyone. Bye-bye.

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