For 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?

Also referred to as “dissociation,” disassociation describes situations where the femoral head (the round, ball-like part of the hip implant) actually breaks away from the stem of the hip implant. The image at right helps illustrate what these parts do and roughly where the dissociation would occur.

What Causes the Stryker LFIT V40 Dissociation Failures?

The main reason for dissociation in LFIT V40 artificial hips is corrosion where the femoral head joins the femoral stem. This usually starts slow and goes unnoticed by the patient for many months and even years. Over time, the corrosion gets worse and likely causes metallosis. Once enough time passes, the corrosion gets so bad that the head and stem joint break apart or disconnect leading to a catastrophic failure of the hip implant.

What Causes the Corrosion?

The corrosion could be caused by excessive friction between the metal components. Ideally, when the femoral head is attached to the femoral stem, it is a perfect joint, with no movement between the two parts. Unfortunately, the Stryker LFIT V40 components often wouldn’t be properly connected. This could lead to micromotion, or a very small amount of “wiggling” between the parts. Too much movement or grinding can cause the neck to grind down (sometimes referred to as “penciling”), where the neck grinds away to a sharpened point, like a pencil. Ultimately, this could result in corrosive wear and create a dissociation failure.

How Can I Tell if My Hip Replacement Has Disassociated?

If your artificial hip implant disassociates, you’ll most likely know something is very wrong with your hip. You will likely endure one or more of the following symptoms:

• Pain and/or inflammation (the pain is often significant).
• Joint instability.
• Metallosis.
• Reduced mobility (even inability to walk).
• One leg becoming longer or shorter.
• Broken bones in areas surrounding the joint.

What Do I Need to Do If My Stryker Hip Implant Disassociates?

You’ll almost certainly need hip revision surgery (most likely, immediately). Because the corrosion leading to dissociation will be severe, this surgery will likely be extensive, requiring not just the femoral head to be replaced, but also the femoral stem. The removal of the femoral stem is a big deal because it will probably be very well-established in your femoral bone. The femoral stem can be removed, but it won’t be a pleasant experience.

I’m Feeling Fine Right Now, So Now What?

The first thing you can do is talk to your doctor to confirm if you received the affected Stryker LFIT V40 hip components. If you did, you’ll need to discuss the medical benefits of removing the V40 femoral head. If you’re lucky, only the head will need to be replaced and the femoral stem can be left alone. While this still requires revision surgery, it’s a far less complex or involved procedure. As always, rely on the advice of a trusted orthopedic surgeon for these medical decisions.

To learn more about potential issues with your Stryker LFIT V40 hip implant and what legal options you may have available, you can contact my office or call me at (919) 830-5602

Smith & Nephew Birmingham Hip

The 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.

In Smith & Nephew’s Birmingham Total Hip Arthroplasty (THA) the artificial hip is constructed with Smith & Nephew BHR components and non-BHR components, but instead of resurfacing the ball-bone with a metal covering as in the resurfacing procedure, the bone is removed and a metal ball component is implanted.

Cases involving failed Smith & Nephew’s resurfacing hips and THA hips are now consolidated in multidistrict litigation No. 2775 in Baltimore, Maryland. Litigation is currently active and the first bellwether trial for a BHR case is scheduled for spring of 2020. In January 2019, mediation was held to attempt settlement for most of the S&N THA cases, but that mediation was not successful (at least, at that time). I suspect the litigation to continue for another eighteen months at least.

Stryker LFIT v40

Unlike other artificial hips currently in litigation, the Stryker LFIT V40 Hip is not a metal-on-metal artificial hip. The LFIT V40 system includes a metal acetabular cup, a polyethylene (or plastic) liner, a cobalt-chromium femoral head, and a titanium femoral stem. The failure of the Stryker LFIT V40 involves the junction of the neck of the femoral stem and the femoral head or ball. The neck connects and attaches to the femoral head (the ball), thus connecting the leg bone to the hip bone. This connection was intended to be permanently secured through a taper lock system, holding the stem securely to the ball. In many cases, however, once implanted the V40 femoral head began to corrode. The corrosion occurred at the site of the connection to the neck. Over time the corrosion can cause the taper lock to become compromised and loosen. Eventually, the neck would corrode as well, and once the neck began to corrode the breakdown of the artificial hip would advance more quickly. According to one study, the loosening would cause fretting and micro-motion at the taper lock site, and this movement or friction would cause metals to be released into body. Thus, the Stryker metal-on-polyethylene (MoP) artificial hip resulted in patients suffering from metallosis, just like other patients who received metal-on-metal artificial hips.

In November 2018 Stryker Orthopaedics reached a settlement in the multidistrict litigation involving the LFIT V40 hip. The settlement involves approximately 125 cases in the federal court MDL and an additional 140 cases in New Jersey state court. Although this agreement settles many lawsuits previously filed in the MDL, there remain many lawsuits that were later filed and have not been resolved, so this litigation is not over. I believe Stryker will work to extend the settlement agreement to the remaining claims, or the litigation will need to ramp up again very shortly.

DePuy Pinnacle and ASR

The DePuy Pinnacle litigation has been slow-going. DePuy Orthopaedics stood by the Pinnacle device in a way it did not with the ASR. For one thing, it did not officially recall the Pinnacle hip, as DePuy did with the ASR. The Pinnacle MDL was formed in March 2011, just six months after the ASR MDL was established. However, while DePuy recalled the ASR device and entered the first ASR settlement agreement in 2013 (see below) it stood defiantly against allegations of defect involving the Pinnacle. Years passed, and thousands and thousands of individuals filed suit against DePuy and Johnson & Johnson for injuries caused by the Pinnacle. One Pinnacle bellwether trial after another came and went, and still the plaintiff and defense teams could not reach a larger settlement. As of today no global settlement has been reached, and the litigation is far from over.

The DePuy ASR hip litigation has been powering along for a decade. On August 24, 2010 DePuy Orthopaedics announced a worldwide recall of the ASR artificial hip system. In November 2013 the first Settlement Agreement was reached in the ASR multidistrict litigation. To qualify for this “first” settlement the injured plaintiff must have had revision surgery to remove the ASR hip by August 31, 2013. The second agreement included plaintiffs whose revision surgery occurred on or before January 31, 2015. The third settlement agreement offered settlements to those injured people who had revision surgery on or before February 15, 2017. And then everything . . . stopped. Many court watchers believed a “fourth” settlement would be reached to resolve the hundreds of cases involving plaintiffs whose ASR revision surgeries occurred after February 15, 2017, but so far, nothing. Currently over 1,600 people have cases filed and pending in the ASR MDL. I expect either a new settlement extension to be announced or an order from the judge remanding these remaining cases to their home courts for further litigation and trial.

Note: All information in this article is distilled from publicly-available information, including media reports, and my previous posts.

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.

I have written about the LFIT V40 femoral head product failure several times in the past. Problems with the hip component began several years ago. On August 29, 2016, Stryker announced a recall for the LFIT V40 head. The recall focused solely on the femoral head, which is the “ball” part of the hip replacement. This femoral head fits inside the “cup” and is also attached to the “stem” (which is connected to the femur, or thigh bone).

The recall involved LFIT V40 heads manufactured before 2011 with the following catalog numbers and sizes:

LFIT V40 Femoral Head Is a Metal-on-Polyethylene (MoP) Artificial Hip

Unlike many other artificial hip product failures, the Stryker LFIT V40 not part of a metal-on-metal artificial hip system. The LFIT V40 system is built utilizing a metal acetabular cup, a polyethylene (plastic) liner, the LFIT V40 cobalt-chromium femoral head, and a titanium femoral stem. Unfortunately, soon after being sold and implanted, the Stryker LFIT V40 began to fail, at a high rate. Patients who received the Stryker LFIT V40 suffered similar symptoms as those who received metal-on-metal hips, including metallosis.

LFIT V40 Taper Lock Failure

The failure of the Stryker LFIT V40 involved the junction of the neck of the femoral stem and the femoral head or ball. This connection was intended to be permanently secured through a taper lock system, holding the stem securely to the ball. However, in many cases the LFIT V40 femoral head began to corrode, which means to disintegrate and lose metal. The corrosion occurred at the site of the connection to the neck (the taper lock). This corrosion in the head would progress slowly, but over time the corrosion would cause the taper lock to loosen. Eventually, the neck would corrode as well, and once the neck began to corrode the breakdown of the artificial hip would advance more quickly. One study found that the loosening would cause fretting and micro-motion at the taper lock site, and this friction would cause metals to be released into body. Thus, the Stryker metal-on-polyethylene (MoP) artificial hip resulted in patients suffering from metallosis, just like so many other patients who received metal-on-metal (MoM) artificial hips.

Keep in mind that the corrosion in the LFIT V40 can be slow. This means you may not know the Stryker hip is failing and releasing cobalt and chromium into the body for years. By then, the neck may have begun to corrode, and when that happens the femoral stem may need to be removed and replaced, which can be a very difficult surgery. The femoral stem is implanted down the center of the femur bone, and when it sets it is usually there permanently. Removing the femoral stem is difficult and painful.

Check back here for updates on the Stryker LFIT V40 femoral head settlement. And if you believe you have a failed artificial hip in your body, call me to discuss: (919) 830-5602.

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

The Stryker LFIT V40 Hip is not a metal-on-metal artificial hip. The LFIT V40 system includes a metal acetabular cup, a polyethylene (or plastic) liner, a cobalt-chromium femoral head, and a titanium femoral stem. The exploded-view diagram at top right gives you an idea of how the Stryker LFIT V40 hip is assembled. Stryker avoided the problematic construction of direct metal-on-metal components.

So far so good, right? Well, unfortunately, no. Soon after being released into the market, the Stryker LFIT V40 began to fail, at an unusually high rate. And patients who received the Stryker LFIT V40 were suffering from similar symptoms as those who received metal-on-metal hips. Even, oddly, diagnoses of metallosis. It was an unexpected result. So what happened?

Something called a taper lock failure. Let’s take a closer look:

The LFIT V40 Taper Lock Failure

The failure of the Stryker LFIT V40 concerns the junction of the neck of the femoral stem and the femoral head or ball. In the illustration above, the neck is that small metal rod that extends out from the femoral stem. The neck connects and attaches to the femoral head (the ball), thus connecting the leg bone to the hip bone. This connection was intended to be permanently secured through a taper lock system, holding the stem securely to the ball.

But as it turned out, in many cases once in the body the V40 femoral head began to corrode, which means to slowly disintegrate and lose metal. The corrosion occurred at the site of the connection to the neck (the taper lock). This corrosion in the head would progress slowly, but over time the corrosion would cause the taper lock to become compromised and loosen. Eventually, the neck would corrode as well, and once the neck began to corrode the breakdown of the artificial hip would advance more quickly. According to one study from 2016, the loosening would cause fretting and micromotion at the taper lock site, and this movement or friction would cause metals to be released into body. Thus, the Stryker metal-on-polyethylene (MoP) artificial hip resulted in patients suffering from metallosis, just like so many other patients who received metal-on-metal artificial hips.

The corrosion in the LFIT V40 can be slow. This means that the average patient may not know the Stryker hip is failing and releasing cobalt and chromium into the body. It can take years for the loosening to cause problems that are recognizable to the patient. At that point, the neck may have begun to corrode, and when that happens the femoral stem may need to be removed and replaced. This can be a very difficult surgery. The femoral stem is implanted down the center of the femur bone, and when it sets it is usually there permanently. Removing the femoral stem is invasive and problematic and painful.

So How Can You Salvage the Femoral Stem?

You must remove the failing V40 femoral head as soon as possible. This means artificial hip revision surgery. If you remove the head at the beginning of the period of corrosion, and the femoral neck is not corroding, you should be able to revise your artificial hip without the difficult work of removing the femoral stem. But either way, you will have to undergo revision surgery, which is no fun at all. My thought would be: check with your surgeon and confirm the exact components you have in your body. If the doctor reports that you have the Stryker LFIT V40, you need to have a lengthy discussion about removing the v40 femoral head, even if you are not currently having symptoms.

I wrote more about the Stryker LFIT V40 artificial hip here. If you would like to read more on the study identifying failures of the Stryker LFIT V40 taper lock, google Trunnion Corrosion Causing Filure in Metal-on-Polyethylene Total Hip Arthroplasty with Monolithic Femoral Components in Reconstructive Review (April 2016).

Note: I am not a doctor, and this is not medical advice. The diagram at the top is for illustrative purposes only and is not intended to depict the specific Stryker LFIT V40 artificial hip.