Articles Tagged with Stryker

Stryker LFIT v40 disassociationFor a while now, Stryker has had issues with some of its hip replacement artificial implants. One troublesome type in particular has been the LFIT V40 series. Specifically, in some of these Stryker hips corrosion forms where the femoral head connects with the femoral stem. This would often lead to taper lock failure, or a compromised joint that would loosen and cause metallosis.

This issue helped lead to a recall in 2016 and an expanded recall in 2018. One of the reasons for the 2018 recall was a higher-than-expected number of reports of the femoral head disassociating (disconnecting) from the femoral stem.

What Is Artificial Hip Disassociation?

Signs Your Artificial Hip May Be Failing
Not all artificial hips fail. Many total hip replacement surgeries are successful. Unfortunately, artificial hips, particularly “metal-on-metal” hips, have “failed” at a rate much higher than previous artificial hip systems, whose components typically consisted of a combination of metals, plastics, and ceramics. The metal-on-metal design placed a metal ball or head directly into a metal acetabular cup. By using a metal cup and a metal ball, these artificial hips forced metal to rub against metal with the full weight and pressure of the human body. As long as the metals held up, all would be well. But it turned out that this intense pressure and movement often caused the metals to grind and deteriorate, and too often releasing metal particles into the surrounding tissue and into the bloodstream. In other artificial hip failures, such as with the Stryker LFIT v40,  femoral heads can malfunction due to a failure in the taper lock. The taper lock is the part of the hip prosthesis that connects the femoral head to the stem. This can cause the neck on the femoral stem to grind down (sometimes referred to as “penciling”) and can even lead to a full disassociation (more on that below).

In still other artificial hip failures, the plastic liner (between the cup and ball) deteriorates and causes the total artificial hip system to fail. Polyethylene liners are very important in an artificial hip because over the years, it will serve as a buffer between the metal cup and also the metal femoral head or ball, so it can protect against excessive grinding of the hip components. But the studies have shown that Exactech hip plastic liners have been breaking down and showing signs of premature wear.

Please note that with any hip replacement surgery, there will be a period of rehabilitation. Even with great surgery results, the patient will suffer some soreness, stiffness, and a period to regain strength, mobility, and comfort. From the hundreds of people I have spoken with over the years who have undergone hip replacement surgery, even successful hip replacements do not turn you into a completely pain-free eighteen year old athlete.

If you’re reading this you probably know that over the past decade thousands and thousands of lawsuits have been filed by people injured by defective artificial hips. Several manufacturers have been involved, and while a few companies have resolved claims and moved on, thousands of other artificial hip lawsuits remain in courts across the country. Let’s take a look at active litigation involving artificial hips:

Smith & Nephew Birmingham Hip

Patient with Smith & Nephew BHR artificial hipThe Smith & Nephew “Birmingham” hip litigation is in full-swing. Plaintiffs in this litigation allege they were injured after receiving a Birmingham Hip Resurfacing (BHR) device, or a total hip arthroplasty (THA) utilizing Birmingham Hip components. In the resurfacing procedure, the  hip ball bone is shaped and resurfaced with a smooth metal covering and a metal shell is implanted into the hip socket, thus creating a metal-on-metal connection. Smith & Nephew uses cobalt and chromium to construct both of these resurfacing components. These metals have been shown to wear away and move into the blood and tissue of the patient, causing all kinds of symptoms and problems.

Artificial Hip Joint Showing femoral head and femoral neck and stem
Stryker Orthopaedics has announced that it reached a national settlement in the multidistrict litigation focused on the Stryker LFIT V40 femoral head. The LFIT V40 femoral head is one component of Stryker’s artificial hip system. This settlement announcement is a bit surprising, as the MDL was created for the LFIT V40 femoral head in April 2017. As medical device multidistrict litigation goes, this is a very quick path from formation of the MDL to settlement. One reason for the speed is that this MDL is smaller than other artificial hip MDLs based on the number of injured plaintiffs. The LFIT V40 settlement involves approximately 125 cases in the federal court MDL and an additional 140 cases in New Jersey state court.

In any event, for those people hurt by the LFIT V40 femoral head, this is good news. The terms of the settlement have not been released. I will certainly update this website when the settlement agreement is made available. As for now, all discovery and trial preparation have been stayed (or stopped). The first bellwether trial, scheduled for September 2019, will be removed from the trial calendar. The focus now will be on processing individual settlements for plaintiffs.

Remember that each plaintiff in this or any other medical device litigation is not required to accept the settlement. Although it is often reasonable for the plaintiff to accept the terms of settlement, no plaintiff will be compelled to accept any settlement. As with any litigation, it is important for individual plaintiffs and their attorneys to slow down, review all the terms of settlement, and make a careful decision on whether to participate in the settlement.

Artificial Hip System
The vast majority of artificial hip failures over the past decade involved metal-on-metal (MoM) hip components. These medical devices were meant to revolutionize the artificial hip market. Specifically, the all-metal hip components were intended to last a long time, and much longer than older generation artificial hips using materials like ceramics and plastics, which had a tendency to wear down and “fail” after twelve or fifteen years. Beyond that, the metal-on-metal artificial hips were touted to withstand the rigors of active, athletic patients. It sounded like a terrific advancement in the development of artificial hips. The problem is, the metal-on-metal design did not work, in many cases because the metal acetabular cup and the metal femoral head would grind together day after day, month after month, releasing harmful metal debris (metallosis) into the patient’s body. Far too many people were forced to get revision surgeries a few years after the implant surgery to remove the metal hips.

It turned out to be a disaster for thousands of patients and for several large medical device manufacturers. Depuy and Zimmer, to name just two companies, faced thousands of lawsuits from people injured by the metal-on-metal artificial hips. Many of those cases are resolved or resolving, but many more await settlement or jury trials.

The LFIT V40 Is a Metal-on-Polyethylene Artificial Hip

Stryker LFIT V40 Artificial Hip MDL
We’ve previously blogged about Stryker LFIT V40 artificial hip problems, discussing a recall made back in August 2016 and how to tell if you have an artificial hip that’s part of that recall. Since those posts a lot has been going on in courthouses across the country, with dozens of lawsuits popping up from individuals who received affected artificial hips made by Striker Orthopaedics and its subsidiary, Howmedica Osteonics Corporation (HOC).

Just recently, approximately 33 pending lawsuits against HOC were consolidated into a multi-district litigation (MDL). In a way, you can think of this consolidation as a “things just got real” moment for HOC. But what’s the big deal about the Stryker LFIT V40 litigation now being in MDL status? Let’s begin by discussing the underlying lawsuits.

Why Are the Plaintiffs Suing?

Orthopedic Surgeon with X-Ray of Stryker LFIT V40 Femoral Head

I imagine it can seem overwhelming. Let’s say you had artificial hip surgery in 2011. By 2016 you begin to feel some unusual, new pain. So you Google artificial hip implants and you discover an ocean of words on the many failed artificial hip components that have been sold and implanted (and then failed) over the past decade. Then you run across an article on an urgent recall of  the Stryker LFIT Anatomic CoCr V40 Femoral Head (let’s call it the V40 Head). You have a vague recollection that you were implanted with a Stryker artificial hip back in 2011, but you certainly don’t know if the V40 Head was implanted. So the question for a person like you would be: How do I know if I have the Stryker LFIT Head implanted in my body?

It’s a great question. In fact, you should not be expected to know what precise artificial hip components have been implanted in your body. I had cataract surgery last year, and I don’t have any idea what exact artificial lenses were implanted in my eyes. I hope I don’t ever have to figure out what product they actually are. But back to you. Here is a simple procedure you should follow if you need to find out if a medical device like the V40 Head is currently implanted in your body:

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Total hip replacements are becoming more popular. Between 2000 and 2010, the number of individuals aged 45 years and older receiving total hip replacements more than doubled, rising from 138,700 to 310,800. One of the reasons for the increase is a result of medical and technological advancements in hip replacement surgery and artificial hip components.

Patient with Stryker LFIT Artificial Hip

Unfortunately, not all artificial hips have performed as intended, resulting in serious complications for many patients. I have written often about failed artificial hips on this site. One such example has occurred with the Stryker Orthopaedics’ (Stryker) LFIT V40 femoral head. On August 29, 2016, Stryker issued a voluntary recall for this particular hip replacement product. If you or someone you know may have received this hip replacement product, there are certain things you need to know.

What’s Being Recalled?

This isn’t the first time Stryker has had a problem with its hip replacement products. Back in 2012, Stryker recalled its Rejuvenate and ABG II modular-neck hip stems. However, the current recall concerns the LFIT Anatomic CoCr V40 Femoral Head (V40 femoral head).

The recall focuses not on the entire hip replacement prosthesis, but rather just the femoral head; the femoral head is the “ball” part of the hip replacement. This femoral head fits inside the “cup” (which is located in the pelvis) and is also attached to the “stem” (which is connected to the femur, or thigh bone). Neither the cup nor the stem are currently a part of this recall.

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Clay, thank you sir for making a disheartening experience at least palatable, you and your staff were honest, caring and understanding through the entire process of my wife’s hip replacements, while monetary settlements never make the pain and suffering end, it sometimes is the only way people can fight back to right a wrong. J. V.
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