Hip replacements often use a variety of exotic metal alloys or ceramics to recreate the ball-in-socket mechanism of the human hip. A total hip replacement will typically consist of four parts:

• The socket (or acetabular component).
• The ball (or femoral head) that goes into the socket.
• A liner for the socket that is in direct contact with the ball.
• A stem for the ball (also known as a femoral stem) that connects the ball to the thigh bone (femur).

The liner is placed into the socket and the socket is placed into the pelvis. The ball attaches to the stem and the stem attaches to the femur. The result is a total artificial ball-in-socket hip replacement.

Sometimes, these hip replacements don’t work as expected. One such example comes from Zimmer US, Inc. and related companies (which we’ll collectively refer to as “Zimmer”). Many patients have reported problems with a particular set of Zimmer femoral head and stems.

What’s Wrong with Zimmer’s Artificial Hips?

At issue are two femoral stems: the M/L Taper Hip Prosthesis and the M/L Taper Hip Prosthesis with Kinectiv Technology. When either of these components is paired with the Zimmer VerSys Hip System Femoral Head, many artificial hip recipients have reported a variety of problems, such as:

• Metallosis (elevated metal levels in the body)
• Osteolysis (destruction of bone tissue)
• Pseudotumor formation

Often, any of these problems require revision surgery, which is surgery to replace the failed implant. It’s believed that many of these hips are failing due to corrosion, trunnionosis and the release of tiny bits of metal at the point where the femoral head connects with the femoral stem.

Have Patients with Failed Zimmer M/L Hip Replacements Taken Legal Action?

Yes. There have been hundreds of plaintiffs who have filed suit against Zimmer alleging defectively designed and manufactured hip components, Zimmer’s failure to warn patients and doctors about the risks of using the hip replacement and that Zimmer did not properly test the artificial hip components.

With so many lawsuits consisting of similar injuries and allegations, along with a single (or small number) of defendants, our court system has a special system in place to consolidate the cases for pre-trial matters. This consolidation is called multi-district litigation, or MDL.

The purpose of MDL is to handle much of the pre-trial matters, such as discovery, in a single court with a single judge. With a single judge handling these pre-trial matters, the cases can be processed more efficiently, as the judge’s decisions will apply to all cases at the same time.

The ultimate goal is to reach a comprehensive settlement that resolves all of the cases fairly. One way to do with is by having several bellwether trials. These sample cases are supposed to be representative of most of the cases in the MDL. Therefore, how they turn out can serve as a signal of what the plaintiffs and defendants can expect if their respective cases go to trial.

How these bellwether cases turn out will shape how settlement negotiations will go. As you can imagine, the better they go for the plaintiffs, the more negotiating leverage plaintiffs will have during settlement talks.

Right now, the Zimmer lawsuits involving the M/L Taper Hip Prosthesis, the M/L Taper Hip Prosthesis with Kinectiv Technology and the VerSys Hip System Femoral Head are in MDL in the US District Court for the Southern District of New York before Judge Paul A. Crotty.

Zimmer MDL’s Current Status

The Zimmer MDL is in the discovery phase, with the first bellwether trial scheduled for January 25, 2021. But if this date is pushed back, don’t be surprised. It was originally scheduled for September 14, 2020, then pushed back to October 19, 2020 and now has this date in early 2021.

All of this to say, there’s a lot of discovery and pre-trial motions to complete before a single trial takes place. As new developments arise in this case, I’ll post an update in this blog. Until then, there’s a long grind of pre-trial matters to get through.

Call me to discuss further: (919) 830-5602.

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.

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.

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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.