Behind every metal-on-metal (MoM) artificial hip that fails, there is a person and a story. Artificial hip manufacturers may see only a faceless crowd of victims. These defendant companies may attempt to resolve the claims in bulk and move on to market the next blockbuster medical device. But in that crowd of plaintiffs are thousands of individuals uniquely injured by a product that was implanted in their bodies. The product failure often requires revision surgery, and the injuries that result from the artificial hip failures change lives forever: accomplished tennis players no longer play tennis; couples no longer travel or walk together on a beach; others have to resign from jobs they love because they cannot sit a desk for any length of time. Each of these people has a unique story to tell.

In the next three posts, I will share one woman’s story. “Suzanne” [not her real name] received a metal-on-metal (MoM) artificial hip in 2006 after years of pain from arthritis. The hip was recalled in 2010, and Suzanne was forced to undergo revision surgery in 2011. This is her story:

Part 1

I have been home in North Carolina from my two month sabbatical in Costa Rica for almost four months now. The memories of my time there, the simple routines, new friendships and the feeling that I would return home and make significant changes in my life after “re-entry” have faded into the urgency of daily demands from work, family, relationships and most urgently: my body. Any time I am away from home I look forward to the pile of mail waiting for me when I return, most of it is junk, I know, but I still get excited by post that is addressed to me personally. Now after two months away from home my stack of mail was significant and I settled into the comfort of my screened in porch in anticipation of what I had missed.

After separating the junk from the catalogs, the catalogs from the bills, the personal emerged and that is where I started. What was waiting for me on that September afternoon among the pile of letters that were a combination of known and unknown, was a curious letter from Duke Diagnostic Clinic. I read it twice to make sure that what I was reading was true and then with an unsettling feeling growing in the pit of my stomach, I looked for my husband John [not his real name]. “John, you are never going to believe what I am reading here in this letter from Duke University. It seems that the artificial hip I received four years ago has been recalled.”

The letter went on to say that only a small percentage of recipients would have complications, but I didn’t need to read any further to know that these were going to be my complications–my life–starting now. Since then I have been traveling the two hundred plus miles back and forth to Durham, the home of Duke University and the Duke medical complex to find that every test that I have taken indicates my device has not only failed, but has been poisoning my blood, damaging surrounding tissue, and quite possibly–we will not know for certain until the surgeons are inside–infecting me.

In the past I spoke of bold action and, with trust, falling into the arms of the universe. Now, faced with major surgery in four days and all of the unanswered questions surrounding this endeavor, I feel like I am falling, but I’m not sure where.

Today was my last day at work before embarking on a two month medical leave to have my left hip re-replaced due to a device “recall.” I left work feeling almost completely satisfied that I could face the impending circumstances with almost no work-related stress or unfinished business. I just have to let it go. I’m finding that I am letting go of a lot of things these days. I will no longer be able to run after my bionic-titanium parts are replaced with more fragile parts. Ceramic, plastic and metal will probably not invoke words from my surgeon like the words after my first hip replacement: “Do whatever you want as long as it does not cause you pain.” Not that pain has ever stopped me before. No pain, no gain, right?

I will miss running though, and I’ll have to face other limitations head-on as they come. Since I am returning home from the hospital mere days before Christmas, I am letting that go too. My family, my husband, and our two children have been trying to create a family holiday experience as far from the consumer, commercial version as we can, spending our time making gifts, cooking food, playing games and music–and if we are not on a traveling adventure–staying home and just having fun. Two years ago our kids, they are twenty six and twenty one now, squirreled away and wrapped random objects from our home so when we woke on Christmas morning, John and I really thought Santa had come. The gifts were spilling out from under the tree, until I looked closer at the bicycle with the big red ribbon tied around it, noticing the rust and dirty tires–who’s bike was that?

In the days leading up to this week I have amassed a stack of books to read while recovering. I have selected various tomes for friends and family as gifts this season and that is all I am doing. Cooking, traveling, creating, taking care of family and friends, I’m letting it go. The first time I had total hip replacement surgery was four years and four months ago. John and I are amazed that we have almost no recollection of what happened the first time I had surgery. We are trying to put the pieces together in order to prepare ourselves this time around, but we have hardly any memory of the experience. This time I have the full support and care of a loving man–my husband of almost twenty seven years. And it’s funny because this second surgery, this “do-over” is like another chance to make all my stories right, to let go of those stories and parts that “no longer serve me,” as one of my wise friends noted.

And so here it is, another chance to let go, another chance to continue creating my story.

Disclaimer: This narrative is not intended to represent any specific person or specific product. Names and details have been changed.

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.