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Articles Posted in Artificial Hip

FDA Issues Warning: Increased Risk of Thigh Bone Fractures With Zimmer Biomet CPT Hip System Femoral Stem

Published on: October 1, 2024 | By Clay Hodges

Artificial hips offer a new lease on life to many thousands of people each year. They provide recipients the opportunity for independent living and mobility they might not otherwise have. Unfortunately, they also come with risks, one of the most prominent being metallosis. But there’s also another potential risk where the femur (thigh bone) could break.

The femur is the largest and strongest bone in the body. Yet the process of implanting an artificial hip, along with the older age of most patients who receive artificial hips, means there’s a greater risk of a thigh bone fracture. If this happens, artificial hip revision surgery may be needed.

The U.S. Food and Drug Administration (FDA) recently issued a safety communication alerting patients with the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper of an increased risk of thigh bone fracture. Let’s take a look at this safety communication and what you should do if you received this implant.

FDA Issues Warning About the Synovo Total Hip System

Published on: February 29, 2024 | By Clay Hodges

Artificial hips offer many patients the opportunity to live active and full lives, but sometimes they don’t always work as intended. Thankfully, these are relatively rare situations. Unfortunately, if it’s your artificial hip that fails, there’s not much comfort in knowing the artificial hips in most other patients work as designed. Because an artificial hip failure can be such a serious problem, the U.S. Food and Drug Administration (FDA) takes steps to ensure artificial hip medical devices receive adequate review and scrutiny before being approved for use in patients. One such step is to confirm that if a company modifies an already approved product, those changes also receive appropriate FDA approval and oversight. Apparently, Synovo Production, Inc. (Synovo) failed to obtain these necessary FDA approvals after making changes to one of Synovo’s hip replacement products. Let’s take a look at what products are affected and what action the FDA has taken.

Affected Medical Devices

Synovo makes the Total Hip System (also known as the Total Hip Replacement System and the Preserve and Endotec BP), which the FDA cleared for medical use. However, the FDA claims that Synovo has made significant modifications to the following three components of this system: Femoral Resurfacing Cup, Acetabular Fixation Cup and Acetabular Bearing. Some of these components are also stand-alone products.

Disassociation Failures in Stryker LFIT V40 Artificial Hips

Published on: January 29, 2024 | By Clay Hodges

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?

Signs Your Artificial Hip May Be Failing (UPDATED 2024)

Published on: January 5, 2024 | By Clay Hodges

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.

Frequently Asked Questions: Exactech Hip, Knee and Ankle Implants

Published on: August 3, 2022 | By Clay Hodges

Exactech Inc. (Exactech) is a company that makes various products to repair or replace joints in the human body. Some of Exactech’s biggest selling products have been replacement joints for hips, knees and ankles. Unfortunately, there have been some problems with certain products suffering from premature wear and other issues. This has led to some patients getting revision surgery to fix the issue and repair damage caused to the human body. Exactech has also started various product recalls involving certain knee, ankle and hip implants. I have prepared the following Exactech FAQs so you can learn more about this problem and what to do if you’re affected.

1. What Exactech Products Have Been Recalled?

The recall involves two groups of products. The first group relates to certain batches of Exactech’s Connexion GXL acetabular hip liners. The second group relates to specific ankle and knee polyethylene liners and inserts, many of which were manufactured in 2004 or later. Some of these products have been sold under the following brands:

Exactech Hip, Ankle and Knee Liners: What’s Wrong With the Packaging?

Published on: June 28, 2022 | By Clay Hodges

Before we talk about Exactech liners and defective packaging, we need to talk about oxygen. Oxygen is necessary for human life, but it’s a fairly reactive chemical element. We don’t think of oxygen as damaging but it can be very reactive. A perfect example of how reactive oxygen can be is fire. Get most things hot enough and they’ll start to react with the oxygen in the air and oxidize rapidly. In other words, they’ll start to burn.

This reactivity many things have to oxygen is one of the major reasons why there’s a recall for Exactech’s hip, knee and ankle implants. No, they don’t catch on fire, but they may have been exposed to too much oxygen before implantation. This could lead to premature wear, damage to bones and the implant breaking while inside the body.

How did the implants come into contact with too much oxygen? It appears to be the result of faulty packaging. Let’s take a closer look at what was wrong with the packaging and why that has allegedly led to problems with the Exactech implants.

Exactech Recall of Plastic Hip, Knee, Ankle Joint Replacement Liners

Published on: June 1, 2022 | By Clay Hodges

Several years ago I wrote a blog post for my product liability website where I encouraged medical device manufacturers to put me out of business. What I meant by writing that article was to say that I would be happy as a lawyer to move on to other practice areas on the day that medical device companies properly tested their medical devices before they put them on the market, ran the appropriate clinical testing, carefully reviewed the studies that came back, monitored the patients who receive the medical devices, and didn’t misrepresent the products in their marketing and advertising materials.

And if all that occurred and product defect injuries dropped through the floor, then I would happily stop practicing product liability litigation and move on to other practice areas. Or go work at my neighborhood bookstore (Quail Ridge Books).

But I also said in that article that it’s unlikely that I would be changing my line of work any time soon, and that was six years ago. And here we are, today, and it’s still the case that there is plenty of work for me to do.

Exactech Hip, Knee and Ankle Liners: Studies Behind the Recall

Published on: March 21, 2022 | By Clay Hodges

Earlier I wrote about how Exactech was recalling many of its ankle, hip and knee liner implants. These recalls were based, at least in part, on several studies about how these implants could suffer from premature wear. This could then require patients to need revision surgery (surgery to repair problems from an earlier surgery) to fix the defective artificial joint.

In this blog post, I’ll take a look at some of these studies and try to explain what these studies found, what their findings mean and why they prompted Exactech to initiate these recalls.

The Materials Used in the Hip, Knee and Ankle Inserts or Liners

Recall Alert: Exactech Hip, Knee and Ankle Plastic Liner Implants

Published on: March 4, 2022 | By Clay Hodges

Exactech Inc. (Exactech) began as a company in 1985 and focuses on developing products for joint replacement. Many of Exactech’s products are used for ankle, knee and hip arthroplasty (surgery to repair or replace a joint in the human body).

Many of Exactech’s joint replacement products have performed well and improved the lives of patients. But over the last fear years, Exactech has learned from multiple studies that some of its ankle, knee and hip products can suffer from premature wear or other problems. Many of these issues could result in the need for patients to undergo revision surgery to replace the device and repair any damage it may have caused to the bone and/or soft tissue.

Exactech has initiated various recalls in response to these problems. The purpose of this blog post is to provide a brief overview of which products have been affected, what’s wrong with these products and what you can do if you’ve had one implanted into your body.

Victim of Defective Artificial Hip: Building Strength After Revision Surgeries

Published on: May 20, 2021 | By Clay Hodges

My friend and former client, a victim of an artificial hip failure, sat down with me for a great conversation last month. You can listen to that podcast episode here. The other day she sent a note to offer a bit more helpful advice to those individuals working to regain strength and physical health after hip replacement surgery and especially after hip revision surgeries:

The one thing that I forgot to say that I think may be important for someone: After several years and seemingly reaching a plateau in my strength and recovery, but still faraway from where I needed to be to walk and function more normally, I started to work with a personal trainer in strength and weight-lifting. Doing mainly squats and deadlifts, beginning with just weighted plastic pipes, and it made a drastic change in my recovery. It would take a very knowledgeable and patient trainer, but the results were significant. Once I achieved a little more strength through a range of motion, I progressed and my gait improved and I could walk without such a limp.

Thanks Clay!

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I was involved in a case for the faulty hip replacements. Clay Hodges represented me. I can't say enough about how much he has helped me. Clay was able to win multiple settlements on my behalf with most of them being the maximum amount able to be awarded. Matt J.

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

We are absolutely pleased with how Clay Hodges handled my husband’s hip replacement claim. He always kept us informed of the progress. And, his work resulted in a settlement which we are extremely pleased. Thank you, Clay! Carol L. & Norm L.