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

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.

For many patients, however, particularly those who received the metal-on-metal hip, there may come a point when they wonder if their artificial hip has failed. But given that all hip surgeries initially come with some discomfort and pain, how do they know if their hip has failed.

Let’s start with the basics:

What Is an Artificial Hip Failure?

Artificial hips fail in several ways:

1. Pain. This would be pain that lingers after the period of rehabilitation, or which arises months or years after the implant surgery. There is no marker for the precise amount of pain necessary to define a failure. If you are in pain, you need to assume that something is wrong and you need to schedule an examination.
2. Swelling. The area around your hip replacement should not swell after the period of surgery and rehab is past. Swelling is a sign of a problem.
3. Metallosis. This is the build up of metal levels in the blood and/or in body tissue. When a metal-on-metal artificial hip cup and ball grind together, tiny shavings can be released into the body, elevating metal levels. A simple blood test can identify metallosis.
4. Loosening components. This is when a component like the acetabular cup has become loose and shifted or moved. It can hurt (see #1).
5. Disassociation. In some cases, the femoral head and stem actually separate or break apart. In these cases, the hip and the leg are no longer connected. This can be caused by (for example) corrosion in the V40 femoral heads.
6. Inflammation of tissue. This is where the hip area becomes swollen, warm, red, and often painful, as a reaction to the hip failure and/or as a result of infection.
7. Pseudotumor. This is abnormal tissue growth that occurs as a reaction to metal particles being released near the site of the hip replacement. A pseudotumor is noncancerous. Pseudotumor does not always cause pain or other noticeable symptoms.
8. Sounds. Other the years, several clients have reported that their hip has begun to make ominous sounds, such as grinding, whistling, popping, or thumping. Your artificial hip should not make noises.

Understand that with most hip failures, several of these conditions may be present, not just one. You may have pain, and swelling, and loosening components. Sometimes you may have all the symptoms.

What Might Artificial Hip Failure Feel Like?

1. Pain. This is nearly always the first red flag. With artificial hip failure, there will likely be unusual pain and discomfort. As doctors like to say, “always listen to your body.” If something doesn’t feel quite right, it may not signal artificial hip failure. But it could.
2. Popping sounds. I’ve had people tell me that their failing artificial hip actually made noises. The popping sound typically comes from a component that is loose or becoming dislocated. It often occurs with pain.
3. Swelling or heat coming from the hip area. A sign of infection.
4. Uncertainty. The hip feels insecure, as if the person’s leg may “give out” while walking or standing. In other cases, the hip feels as if it is locking up on the person.
5. (Almost) nothing at all. Oddly, with some artificial hip component failures, you may not notice symptoms. This is when an artificial hip failure can be most frustrating; something is wrong, but you can’t detect anything serious. For years, one person I spoke with did not feel abnormal pain, but only some discomfort after walking for long periods on hard surfaces (like asphalt). The blood tests showed slightly elevated metal levels, but not outrageously high numbers. After several years, the pain grew incrementally, and the patient eventually chose revision surgery. The revision surgery revealed a very loose cup, dark metallic fluid, inflamed tissue around the hip, and other problems. Clearly the artificial hip components had failed, and revision surgery was necessary, even overdue. But the individual for years believed everything was “good enough.”
6. Other sensations. The human body can simply react in all kinds of ways. If the feeling is unpleasant, something may well be wrong.

Despite all this unpleasantness, there is no need to panic. Panic is not good for anyone. But I do believe you must take ownership of your medical care. If something “does not feel quite right,” schedule an appointment with your orthopedic surgeon. Ask questions. Ask for a blood test. Ask more questions. Keep a symptoms journal, which I wrote about here. Stay after it.

And call me if you have legal questions: (919) 830-5602.

No specific client information was used in writing this article. And of course, I am no doctor, and this is not medical advice.

Clay: Over the past ten years you have seen a lot of metal-on-metal hip implants. Several years ago an attempt was made to put a metal-on-metal artificial hip together, and that was supposed to last forever, or last a whole lot longer, and it turned out that it was problematic. And I know you have had many patients who have had that [implant]. What did you see out of the metal-on-metal hip implants when they were failing?

Amy: Again, the first cardinal sign that I saw was chronic pain, an inability to weight bear normally through that joint. So even after normal hip replacement, the patient should be able to weight bear through it. It should not feel like they collapse on that hip, and so a limp that never resolves or an inability to get away from an assistive device. So, I had a patient in her 50s that could not get off a walker. She was 50. She was playing tennis five days a week before she had her hip replaced. Yes, with the metal-on-metal she suffered metallosis and she had an overt failure of that joint replacement. She was a candidate for this new [metal-on-metal implant], now widely known to be a bad device, because she was so young, active, fit, and healthy. It was supposed to last for longer. It was supposed to allow her to have more function larger range of motion, less risk of dislocation and all of those things. So as we know, that did not really work out so well.

Clay: Yes.

Amy: So the folks that had the metal-on-metal problems, metallosis was the biggest problem that ended up causing really frankly catastrophic changes in these people’s lives because the metals in the two appliances, they ground on each other and it leaks metal, particularly cobalt. That was a big metal that became known to become systemic and to basically create toxicity in the tissue surrounding the joint.

The metal would basically eat or erode away musculature bone, osteolysis was one of the biggest problems where it caused bone to basically just break down and be eroded away. I was actually in the operating room and saw some revision of a hip that experienced metallosis. And in the revision the musculature that was away from the hip, so when you go in to do a hip replacement, obviously, it is an open field and so you can see all of the connective tissue all the layers of musculature of the capsule of the joint this particular patient.

The capsule of the joint was this dingy gray looking color. You knew inherently. You did not have to know anything about science or medicine to know that it is probably not supposed to look like that. And what is astounding was how far away that metal leached into the musculature and so because it is toxic, because it is corrosive, that tissue had to be ripped [out]. It had to be excised. So some people lost part of their musculature and some of it was very important musculature around the hip in regards to stability and mobility restoration in the hip.

So, because the metallosis affected the bone, revision surgeries then became a bit tricky because, so when these folks went in for their first hip replacement, they had this beautiful landscape. They had a bad hip. They had a bad articular surface, but the landscape around it, and by that I mean the bony components that are going to hold that new joint, they were healthy. Otherwise, they would not have been a candidate for a hip replacement. Okay, so they had a healthy landscape to put those two new pieces in the socket. The acetabulum and the femoral head. So, once the metal started breaking down some of the bone, now all of a sudden you have got a landscape. It is not all that great in regards to the how to receive this new joint. So these folks had significantly limited post-op. They had to protect those joints dramatically for long periods of time so that could allow this bone that had really taken a hit to grow into the new prosthesis, which is how you heal a hip replacement. So, it made the post-operative course significantly different than a primary hip replacement where you walk immediately after surgery. I mean, I have seen patients ten days post-op, that are already on a cane and have a pretty decent gait. So–

Clay: Well, that is kind of horrifying, a revision is one thing but a revision when the whole landscape of the hip and the thigh and the leg and all that area is severely compromised. It makes the revision surgery less likely to be successful. So, that gets me to this question. I know you have seen it quite a bit. Tell me what the rehab might look like and I know it is different for all people. But what might the rehab look like for a person who has to get multiple surgeries on the same hip? I know it is compromising. How would it be compromised?

Amy: So that same patient when they had the first hip put in, when as soon as they started physical therapy within 24 hours of their surgery. They would be putting weight if they are usually what is called “weight bear,” as tolerated. So basically, we want you putting weight through that new joint. So as much weight as you feel like you can safely place through that leg using a walker, because everybody starts out on a walker, their weight bear is tolerated.

So, that is in the primary hip replacement that is uncomplicated. In just a plain revision, they can be non-weight-bearing for four to six weeks. So just right out of the gait. They are not putting any weight at all through it for four to six weeks. In the cases where these folks had really substantial metallosis, sometimes that non-weight-bearing was extended 8 to 12 weeks. And now you are talking about being completely non-weight bearing which, by the way, is very difficult to do.

Clay: Yes.

Amy: It is really hard if you think about how difficult that is for your upper body and for your contralateral side, for that other leg to be completely off that leg for anywhere from six to twelve weeks. And the reasoning is because that landscape they wanted, the surgeons wanted, every opportunity for that bone to accept that new part for it to heal because bone is live. So it grows into the prosthesis, into the implanted part of the prosthesis.

So they want that bone grow in because over the course of time, that is where the fixation actually lives. That prosthesis becomes incorporated into the bone itself. It great becomes part of that bone. So that is one of the biggest things that occurs postoperatively in those revisions. And so, then you have to think about everything that happens with that revision. So let us say your non-weight-bearing for six weeks, well, if you took your very healthy hip and you got off of your leg for six weeks, you would be astounded at how much strength you lose.

Clay: All right.

Amy: It is astounding through the entire extremity. And so there is profound strength loss.

Clay: So what is your medical opinion about the likelihood that a follow-up surgery or revision surgery will be successful? I mean does the chance for success just drop through the floor once there has been a failure of an artificial hip? Such that you say to yourself “My goodness. This person is going to really struggle,” or is it case by case? And in a lot of cases revision surgery can be fine for a patient.

Amy: I think that any joint replacement hips included the first one that you get because of that pristine landscape is the best chance you have to have a great outcome. Every time that that surgeon has to go back in, the opportunity for a great success go down.

Clay: Right.

Amy: And that is just the way it is. But the problem is that, like for the folks that had these metal-on-metal joints, they did not have an option. I mean, they were in such profound pain. The debility they had to get that hip taken out. And they just basically had to deal with whatever that metal did to the surrounding tissue and they had to try to protect the healing tissue the best they could and understand that their outcomes were going to be less than perfect.

Clay: Right.

Amy: Not what they had planned. Not what my fifty year old patient who had every plan of going back to the tennis court because that is why she had a hip replacement, because we know that she can go back to doubles tennis.

Clay: Right. Did not happen.

Amy: No, matter of fact, she was just happy frankly at the end of the day after a exhausting very very physically and emotionally challenging rehab process. She is happy to be able to walk and to not feel like she has a nail being driven through her hip every time she way bears.

Clay: I see.

Amy: So her measure of success changed dramatically after her revision.

Clay: I bet. Well, let me try to end on a slightly more upbeat note. Have you seen better outcomes in the last few years since we have learned what we have learned about metal-on-metal hips? And have there been fewer revision surgeries among your patient population?

Amy: There absolutely have been. As matter of fact, it probably in the last four years, I have had quite a few patients that have not even needed to do anything with me postoperatively. They were strong enough, healthy enough, and had prepared themselves for their surgery enough that they did not even need to do PT. Basically, they just had to protect their hip for a little bit, gradually get their weight back on it. And so, there is no question that the hip surgery that is going on right now, the total hip replacement surgeries, and I am seeing are phenomenally successful. If we look at the whole spectrum of success, I think the last that American Academy of Orthopedic Surgeons was a 95% success rate. I mean that is pretty high success rate for a very dramatically large spectrum of people [aged] 11 to the 90s. So, you know, it inherently has great outcomes. It is just when the outcomes are not great, it is bad.

Clay: Yes. I have seen it in my work as well. This is what I wanted to talk to you about today. This has been fantastic.

Amy: Well, I hope I answered your questions adequately, and I am happy to talk with you.

Clay: Well, thank you so much and who knows, if I have another subject to discuss, maybe we can do this again one day.

Amy: I would love to do that, Clay.

Clay: Well, thank you Amy. I really appreciate your time.

Amy: My pleasure. Have a great night.

Clay: You too.

Note: You can also listen to this conversation with Amy Dougherty in my podcast. If you want to talk about a possible defective artificial hip case, call me: (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.

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?

Patients who received the Stryker LFIT V40 femoral head suffered from a variety of problems with their artificial hip, including extreme pain, cobalt/chromium poisoning, inflammation, joint instability, loss of movement and joint dislocation. These symptoms were the result of a taper lock failure.

The major claim made by plaintiffs is that the taper lock failure was caused by corrosion at the taper junction, which is the part of the hip implant where the LFIT V40 femoral head attaches to the hip stem. Plaintiffs also argue that not only were the LFIT V40 femoral heads defective, but Stryker and HOC knew of these problems and failed to properly warn the doctors who performed surgeries to implant these artificial hips.

Over time, the taper lock failure resulted in metallosis, a serious condition where metal debris builds up in soft tissue, as well as the LFIT V40 femoral head completely separating from the hip stem.

Why Did the Plaintiffs Want Their Lawsuits to Be Consolidated in One Court?

There are several possible reasons why the Stryker LFIT V40 plaintiffs wanted their cases consolidated.

First, it allows plaintiffs to pool their resources and coordinate their legal strategies. This means they can litigate more efficiently and save money.

Second, litigation can occur faster. This is usually good for the plaintiffs, because they can obtain compensation sooner. It also prevents defendants from dragging out a case.

Third, cases consolidated into an MDL get a lot of attention (even, I suppose, this article). The extra media attention can bring in even more plaintiffs. With more money at stake, plaintiffs have more leverage during settlement talks.

In this case, HOC was concerned about extra negative attention. As a result, HOC argued that the name “Stryker” should be removed from the MDL case name in the hopes that it would avoid some of the bad publicity for its parent company. HOC’s argument was not accepted by the Court and the Stryker name stayed in the MDL case name. It is now, “In re: Stryker LFIT V40 Femoral Head Products Liability Litigation.”

The Decision to Consolidate

The decision to transfer was made by the United States Judicial Panel on Multi-District Litigation (JPML). Plaintiffs argued that since all the cases involved one or more common questions of fact, consolidation into an MDL would promote judicial efficiency and be more convenient for the litigating parties.

HOC disagreed, arguing that there were only a “few” cases, so consolidation wasn’t necessary. HOC also argued that even though all the cases involved the same LFIT V40 femoral head, because there were a wide variety of hip stems used by different patients, it didn’t make sense to consolidate the cases. The JPML disagreed with HOC and consolidated all 33 cases into an MDL.

Next Steps

The 33 Stryker LFIT V40 lawsuits from 17 total federal districts will be transferred to the District of Massachusetts, and handled by Judge Indira Talwani, who is already hearing several Stryker LFIT V40 cases. However, Judge Talwani has never handled an MDL and has only been a federal judge since May 2014.

The cases will now advance to pre-trial matters, primarily discovery. In the meantime, additional cases may also be added to the MDL.

Once discovery is complete the cases will be transferred back to their original federal districts for trial. Before that happens, the Court will try to get the parties to settle the cases. One way to promote settlement is to have bellwether trials.

Bellwether trials are cases that represent the whole group. Bellwether cases will go to trial and be tried by a jury. How these cases turn out will provide insight to the parties as to whether a settlement is possible and if so, what the settlement terms should be.

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:

more Do You Feel Pain?

The first question you should ask if: Do I have pain? If you have great results from your hip replacement surgery, you may not need to confirm what specific parts are in your body. Although I think information is always a good thing, if your results are good, you may just take a wait-and-see attitude. After all, the artificial hip is not going anywhere.

If you have pain in the hip area, or in your legs or back, then you need to begin keeping a pain journal. I have written about this simple information-gathering tool, and it is an important action to take. It will likely help your doctor diagnose the problem, and it may help your attorney with your product liability case down the road.

Did You Receive a Recall Letter?

For many recalled medical devices, the manufacturer often sends a letter directly to the patient identifying the recalled medical device, or the company sends a letter to the patient’s surgeon asking the surgeon to notify all his or her patients who received a recalled product. From what I understand, Stryker did not send any such letter to patients or doctors. So in the case of the V40 Head, a recall letter will not help you figure out if you have the V40 Head in your body, because one was not mailed.

Stryker did issue an Urgent Medical Device Product Field Action Notification for the LFIT Anatomic CoCr V40 Femoral Heads, which you can read here: Stryker LFIT Urgent Notification. This Urgent Notice was delivered on August 29, 2016 to surgeons and hospitals who may have received the V40 Heads in the last fifteen years. But Stryker did not send the letter directly to the patient who had the V40 Head implanted. Without direct notification from Stryker to you, the patient, it therefore falls to your surgeon to let you know about the recall. And your surgeon may or may not voluntarily tell you about the recall.

Ask Your Doctor

If you are feeling pain as described above (and maybe even if you are not), you need to visit your surgeon. Schedule an appointment and let your surgeon explain to you what is going on. At that doctor’s visit, you should ask if your artificial hip components are subject to any recalls or other product failure issues. If you have the V40 Head implanted, your surgeon absolutely should let you know at that point that you have the V40 Head implanted. He or she should then tell you what you should do next, at least from a surgical or medical treatment standpoint.

Ask for the Product Stickers Page

Now you are getting somewhere. Whether you meet with your surgeon to discuss the new and different hip pain, you have the right to all your medical records. Call the surgeon’s office and ask the person in charge of medical records to send you copies of the “product stickers” page. This is a simple page that has all the hip component labels affixed to the sheet of paper. When you had the original implant surgery, the surgical nurse should have carefully removed all stickers from each hip component and stuck the label to the product stickers page. It may have a heading at the top that states “nurses’ notes” or “hospital notes” or “operative note,” but any product stickers page is unmistakable, because the product stickers or labels has all the key identifying information: name of the component, lot number, reference number, manufacturer’s name and logo. When you have the product stickers page in hand, you are on your way to establishing whether you have the Stryker LFIT V40 Head implanted.

While you are asking for the product stickers, feel free to ask for all medical records relating to your original implant surgery. These documents can prove very helpful in the early going to a product liability lawyer.

Call a Lawyer to Discuss

A good product liability lawyer will be able to help you identify whether you have the V40 Head implanted, especially if you have obtained the product stickers page. But even if you haven’t recovered that page from your surgeon’s office, a lawyer can figure it out for you.

Recap on the Stryker LFIT V40 Femoral Head Failure

Stryker has admitted that a higher than expected number of its V40 Heads are malfunctioning 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. When the taper lock fails, various symptoms can result, such as:

– Loss of movement – Joint instability – Legs of differing lengths – Severe pain – Annoyance – Inflammation – Joint dislocation

These symptoms can be caused by any of the following:

– Metallosis – Fractured hip stem trunnion – Disassociation of femoral head from hip stem – Excessive wear debris – Insufficient soft tissue tension – Loss of implant: bone fixation strength

These are just some of the possible symptoms and hazards associated with a failing V40 Head. Two of the more serious issues are metallosis and disassociation of the femoral head from the stem.

The exact cause of taper lock failures in the V40 femoral heads has not yet been provided by Stryker. But regardless of how the V40 femoral head is defective, if you are suffering any of the above symptoms, there’s a good chance you may have a V40 femoral head hip replacement component that needs to be fixed or “revised.”

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.

more

Not every V40 femoral head is being recalled. The recall includes those manufactured before 2011 that have the following catalog numbers and sizes:

Many patients who received the V40 femoral head also received additional Stryker hip replacement components, such as the Accolade TMZF, Accolade 2, Meridian and Citation stems.

What’s Wrong With the V40 Femoral Head?

Stryker has observed that a higher than expected number of its V40 femoral heads are malfunctioning 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. When the taper lock fails, various symptoms can result, such as:

– Loss of movement – Joint instability – Legs of differing lengths – Severe pain – Annoyance – Inflammation – Joint dislocation

These symptoms can be caused by any of the following:

– Metallosis – Fractured hip stem trunnion – Disassociation of femoral head from hip stem – Excessive wear debris – Insufficient soft tissue tension – Loss of implant: bone fixation strength

These are just some of the possible symptoms and hazards associated with a failing V40 femoral head. Two of the more serious issues are metallosis and disassociation of the femoral head from the stem.

Metallosis occurs when metal particles build up in human tissue. This can cause inflammation, metal poisoning and necrosis. The metal particles are created when bits of the hip replacement wear away due to the grinding and rubbing that occurs within the hip replacement over time.

Disassociation of the femoral head from the stem is another way of saying that the femoral head and stem break apart. This can be caused by corrosion in the V40 femoral heads.

How Can These Issues Be Fixed?

The exact cause of taper lock failures in the V40 femoral heads has not yet been provided by Stryker. But regardless of how the V40 femoral head is defective, if you are suffering any of the above symptoms, there’s a good chance you may have a V40 femoral head hip replacement component that needs to be fixed or “revised.”

In order to fix the problem, many patients will need revision surgery. Revision surgery is basically another hip replacement surgery to remove the problematic hip prosthesis component and replace it with a different one. As you can imagine, a revision surgery is the last thing a hip replacement recipient wants to go through.

So What Now?

If you are the recipient of a Stryker LFIT V40 femoral head subject to this recall (or believe you may be), you should see your orthopedic surgeon as soon as possible, regardless of whether you’ve experienced problems with your hip replacement.

If you have suffered some of the symptoms described in this blog, you may want to consider having your situation reviewed by a competent product liability attorney. You may call me at (919) 830-5602 or send me a message. Either way, good luck.

Artificial hips have been failing for years now. The effort in the last two decades to build and market a metal-on-metal hip that might last the patient’s lifetime has not been a success. The manufacturers were too quick to move the new metal hips to market, and using the flawed 510(k) fast-track process, they did not test the devices sufficiently to understand the risks. As a result, thousands of people suffered through hip replacement surgery failure and had to undergo revision surgery, just months or a few years after the original surgery. Because of these hip failures, thousands of lawsuits have been filed. The litigation continues for many people, and will continue for years. Still, because most of the failed medical hip products were recalled or taken off the market years ago, the litigation is plainly winding down with several of these artificial hip devices. So what’s still going on? And what does this mean for you?

more Depuy ASR

This was a big one, and I have written about it extensively on this website. Two settlement agreements have been reached in the multidistrict litigation (MDL), several cases have been tried to juries, and thousands of lawsuits have been settled. Of course there is still time to bring a lawsuit against Depuy for the failure of the Depuy ASR hip system, but the window is closing. Two key facts are required: (1) did you have the Depuy ASR hip implanted in your body? and (2) are you having problems with your hip? If you answered yes to both, you need to get answers to your medical questions and legal questions immediately. Keep in mind that your state’s statute of limitation, which sets a limit on the time you can file a claim, is always a critical issue for an injured person. Don’t wait.

Depuy Pinnacle

Depuy Orthopaedics (and Johnson & Johnson) also marketed and sold an artificial metal-on-metal hip known as the Depuy Pinnacle Hip Replacement System. I wrote about the basics of the Depuy Pinnacle hip and its litigation here. A key difference between the Pinnacle and the ASR is that Depuy Orthopaedics has not recalled the Pinnacle and has aggressively defended the Pinnacle in litigation, claiming that the device is not harmful and that surgeon error is the cause of the “few” problems associated with the Pinnacle. The multidistrict litigation (MDL) is situated in Texas, but you can certainly bring a claim in any state if you’ve been hurt by the failure of the Depuy Pinnacle. Unlike the ASR, the Pinnacle litigation will last longer because no recall has occurred, which means the products have been out in the marketplace longer and thus have the potential to hurt artificial hip patients, even recently. As of today a second “bellwether” trial is underway in Texas federal court, with Judge Ed Kinkeade presiding (Peterson et al v. Johnson & Johnson Services, Inc. et al 3:11-cv-01941). I will let you know immediately when the jury reaches a decision in that case.

Zimmer Durom Cup

Zimmer Inc. put its Zimmer Durom Acetabular Component (“Durom Cup”) on the market in 2006, so this troublesome artificial hip has been on the market a decade now. More than 12,000 people had the Zimmer Durom Cup implanted between 2006 and 2008 (including several of my own clients). People almost immediately began complaining of pain and injuries, and many had to undergo revision surgery. The allegation is that the metal Durom Cup does not bond with and seal to the hip bone the way an effective acetabular cup is supposed to. Despite receiving thousands of complaints, Zimmer, Inc. has not permanently removed the Durom Cup from the market, and never issued a recall. Nevertheless, I have seen little evidence that the Durom Cup is sold or used much these days.

On July 24, 2015, in Kline, et al. v. Zimmer Inc., et al., a California jury awarded Gary Kline $9.2 million dollars for the failure of the Zimmer Durom Cup. You can read more about that case here.

The key thing about Zimmer Durom is that the product is mostly gone from the market. If you had the Zimmer Durom Cup implanted, and medical problems have now occurred, speak to your doctor and a trusted attorney immediately, as your claim may be close to being time-barred by your state’s statute of limitation. If you don’t file within the time limits of a statute of limitation (often within three years of discovery of the negligence) your claim may well be lost, which means you missed your chance to seek compensation for your injuries against Zimmer Inc.

The MDL is located in New Jersey and is still active.

Stryker Rejuvenate and ABG II

Stryker Corporation placed two metal-on-metal artificial hips on the market in 2008 and 2009: the Rejuvenate and the ABG II. As with most of the metal-on-metal artificial hips, Stryker pushed these products on the market using the 510(k) process. Stryker Rejuvenate and ABG II began causing problems for patients soon after the first sales occurred, and Stryker eventually received thousands of complaints. Stryker voluntarily recalled the Rejuvenate and ABG II in July 2012, citing “potential for fretting and corrosion” at the neck of the hip, which may result in “adverse local tissue reactions, as well as possible pain and/or swelling at or around the hip.” See Stryker Corporation Website.

Because the recall did not occur until July 2012, there is still the possibility that if you had hip replacement surgery between 2008 and 2013, you could possibly have the Stryker Rejuvenate or the ABG II implanted in your body. If you are not having any pain or discomfort, then most likely you should be fine and need to take no action. But if you are suffering abnormal pain and discomfort, check with your doctor to make sure you do not have implanted the recalled Stryker Rejuvenate or ABG II.

I will discuss other companies with pending artificial hip lawsuits in a later post.

Key Takeaway: if you received an artificial hip as part of hip replacement surgery in the last ten years, and particularly in the last three to five years, it is important to be attentive to your body and to your hip. See all your doctors regularly. Keep a close watch on your hip. If something feels wrong, schedule an appointment and figure out what it is going on. It may be a normal result of hip replacement surgery. But it may be one of the failed hip components listed above. If so, there is still time to bring a claim and seek compensation. Good luck.