Below are some of our videos explaining the potential dangers of the Zimmer Biomet Reverse Shoulder, and especially the connection to its high rate of failure. To learn more about the types of injuries that have been linked to this medical device, and the legal claims that have been filed, click Zimmer Biomet Reverse Shoulder.
Ring of Fire Addresses the Zimmer Biomet Shoulder Recall
Farron Cousins: The decision to have surgery is not one that most people in the United States take lightly, but in some cases, cases of extreme injury, extreme illness, surgery is the only option for some patients. That's the case with people, for example, who have to have a hip replacement, or a shoulder replacement, or a knee replacement.
But in a lot of these products that we have seen over the years, the failure rate is abnormally high, and that is what we're beginning to see, with a product put out by Zimmer Biomet. It is a shoulder replacement. For more on this, I have attorney Wesley Bowden here. Wes, thanks for being with me today.
Wesley Bowden: Thanks for having me.
Farron Cousins: So, I guess the first question I have for you today is, this shoulder replacement, put out by Zimmer Biomet. Explain to everybody exactly what it is.
Wesley Bowden: Yeah, so people who have a torn rotator cuff, something that's just degenerated beyond repair, where the doctors can go in there with this simple orthoscope and fix it. They may look at, and their doctors may recommend to them, to get what's known as a comprehensive reverse shoulder.
It's a pretty drastic procedure. It's actually just completely replacing the shoulder, the ball and socket, and actually putting a rod all the way down the arm. So it's a pretty comprehensive surgery. This basically completely replaces their shoulder when the one they were born with wears out.
Farron Cousins: And these products, put out by Zimmer Biomet, these are metal implants. Is this the case?
Wesley Bowden: Yeah, that's right. So Biomet was the company that made it. They later got bought out by a company called Zimmer, so now they've been called, for the last years, Zimmer Biomet. Biomet is no stranger to the medical device market. They've been making products for years and years. What they've done is they've made this device out of cobalt chromium. That's what they originally applied for. They also make it, sometimes, out of titanium.
So based on our research, and what we've been looking at, is it looks like there was a problem with the actual alloy, kind of the formula they used to make this product. What they found was that for units they made between 2008 and 2011, and those would have been implanted all the way up until 2015, they found that their product was breaking at a much higher rate than that of their competitors. So people that were getting this product put in, they're finding that they're having to have a lot more revision surgeries than their other competitors.
Farron Cousins: And any time you have to have one of these implants, whether it is on a shoulder, or a hip, a knee, whatever, people do understand that the new joint, the metal joint, is never going to quite be the same as the old joint, but what they're hoping to do is alleviate most of the pain that they had been having, most of the problems that they had been having.
But when you get a device, that fails, I mean, you're subjecting that person through another very long, very rigorous, very painful surgery and recovery process. I mean, did I get that right?
Wesley Bowden: Yeah, that's right. I mean, look, surgery is, obviously, the most invasive type of procedure you can have done by your doctor, and these people, they're undergoing general anesthesia. They're having rehab. They're running the risk of infection. I mean, sometimes we're seeing cases now, where people have infections resulting from surgery, and it just has a devastating effect on their lives.
So any time that you're undergoing general anesthesia, and you're having a medical device put in, there are some very serious risks that are associated with that. So if you have a product that's put in, and you expect it to basically last you the rest of your life, and that product breaks, well, you're going through that same procedure. You're being put under. You're running the risk of infection, possibly death. So the risks are a lot higher.
No one wants to undergo surgery twice, when you should only be undergoing it once, and that's really what this boils down to.
Farron Cousins: Absolutely, and I know a lot of the time, with these medical devices like this, especially implantable medical devices, they don't necessarily go through the same kind of EPA testing, for example that pharmaceuticals do. In the case of these devices, these implantable devices, these shoulders, hips, knees, any kind of replacement joint, all you have to do is show that this device is similar to something that was already approved, so you get what they call this fast track approval.
To me, I see a lot of problem with that in general, just because we've almost set the system up, in the United States, to allow faulty products to go through with no testing at all, as long as they just say, "Yeah, but my shoulder, it's like the other company's shoulder," so you don't bother testing it. Just get it out there in the hospital as fast as possible.
Wesley Bowden: Yeah.
Farron Cousins: I mean, that's basically what's happening here.
Wesley Bowden: Yeah. It's basically the "Me too" application process, and what it's actually called is, in the FDA, they file what's known as a 510(k) form. What they're doing is they're saying, "We're bringing to market a device that is substantially similar or the equivalent to something else that's already out there." Because of that, when they file it that way, which is the right way to file it, but the way the system is set up, you make a great point.
It doesn't draw the same scrutiny as a brand new device, something that's never been used before. So when they do that, they can have a device that has a different metal structure. They can have a device that's a slightly different size. It can be a different product, but they're saying that it's designed, and it's supposed to be implemented the same way as something else, and therefore it doesn't require as much scrutiny from you, FDA, it just requires your rubber stamp.
As we know, it's no surprise to anyone, our government agencies, they're overtaxed and they're underfunded. I mean, this is something that is not going to fix itself, so what it really becomes is a company's responsibility to act appropriately, to test their devices, and when they see a signal, when they see that too many of these devices are failing, to do what's right, to protect patients' safety, to make sure that people know about these dangers, and that they're educated on it, and so that doctors can be educated on it, too.
In this case, we saw the FDA send out a notice and say, "Hey, this is going to be a recall," and they identified 3,500 of these units that have gone out, that have been implanted in people, and a lot of these people, they don't even know, so while these notices went out to doctors and physicians in hospitals, a lot of the people that we talk to on a day-to-day business, they just say, "Hey, we had no idea. I had no idea that all the pain, and the break that I have experienced, and the second surgery I had to have, I didn't know about that until I saw you, or until I read your article, until I saw you talking about it on television."
So this is a big issue. This is a big problem for people.
Farron Cousins: Absolutely, and you know, 3,500 people out there, with these devices in them, many don't know that this is what they have, so if they do experience additional pain, that may not think it's anything, maybe they moved wrong, maybe they did something. I guess the best advice would be go back to your doctor, find out which device you have in you, and then find out further, what you need to do, if this could be part of the problem with the failure rate that we're seeing with these Zimmer Biomet shoulders, or if maybe it's something else.
Wesley Bowden: That's exactly right, yeah. The first thing you want to do is go back and talk to your surgeon, or to your physician that put this in. Just talk to them about whatever symptoms you're experiencing, whether it's pain, onset of infection, lack of mobility, those are things that you should be talking to with your surgeon or your follow-up physician.
If it is a product that is subject to this recall, and that has been part of the FDA's scrutiny process, then you should consider consulting an attorney, because these are things that we feel the company should take responsibility for, when they put a product out there that was unsafe compared to its competitors. They should own up to it, and help people get better.
Farron Cousins: Absolutely. Wes Bowden, thanks for talking with us today. I truly appreciate it.
Wesley Bowden: Thanks for having me. Take care.
Zimmer Biomet Reverse Shoulder Recall
Hi. I'm Attorney Wes Bowden with the Levin Papantonio Law Firm. Are firm is now investigating Zimmer Biomet Comprehensive Reverse Shoulders. These products are failing at a much higher rate than expected. As a result, the FDA has issued a Class I recall. This is the most serious type of recall. When a Class I recall occurs, the manufacturer FDA believes that there's a reasonable probability that the use of the product will cause serious adverse health consequences or death. Some patients have already received recall warning letters.
If you have undergone a Zimmer Biomet Comprehensive Reverse Shoulder surgery and received a recall letter, call us now. If you have had a shoulder replaced, but don't know what product was used, ask your doctor. If you have suffered bone loss, malposition, or revision surgery as a result of the Zimmer Biomet Shoulder, call us. People who undergo revision surgeries or replacement are at increased risk of permanent loss of shoulder function, infection, or even death.
If you haven't suffered any complications, consult with your doctor and make sure that they continue to monitor you. You should also contact us to preserve your rights in the unfortunate event that it fails later. This is not a suit against your doctor or surgeon and no claim of fault is being made against them. We work on a contingency fee basis, there's no feel unless and until we win for you and you will never be asked to pay costs out of pocket. Don't wait to contact an attorney. Act now. Every state has a strict statute of limitations and a deadline to file your case. Contact us now at the information below.