Articles Posted in Artificial Knee

Oxygen can degrade plastic joint partsBefore 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 Hip Liner RecallSeveral 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 plastic liner in artificial hip system
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

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).

Exactech recall polyethylene liners
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.

Here is a strange cause and effect: if you don’t keep your weight at healthy levels, you may unwittingly become a victim to a negligent manufacturer selling a defective medical device. Which ultimately means your weight gain may one day lead you to me and to becoming a plaintiff in defective product litigation.

It Works This Way:

weight gainLet’s say your job is intense and over the years you begin to neglect your physical fitness. As you get a little older, in this sedentary state, you begin to gain weight. Gaining weight makes you less willing or able to exercise and you gain even more weight. Soon you start to feel aches in your hip or maybe your knees. This pain, over time, gets worse. Finally you consult an orthopedic surgeon, who recommends a total hip or knee replacement. Because you are a trusting soul, and because the hip pain is getting worse, you schedule hip replacement surgery. At this surgery your doctor implants the latest metal-on-metal (MoM) artificial hip components. A year or two later a new kind of hip pain develops, and this hip pain gets severe quickly. Your surgeon does blood work and tells you that your metal levels have spiked in your body and–of yeah, one other thing–you also have a “recalled” artificial hip implanted and that it needs to come out. So you are now forced to undergo revision surgery, and you eventually find your way to me to file a lawsuit over the injuries you sustained from this defective medical device.

Are you one of the almost 5 million Americans who have had total knee replacement or arthroplasty? This surgery is intended to resolve chronic knee pain, often due to rheumatoid arthritis, and restore mobility and quality of life. But sometimes, knee replacements go all wrong. One recent example is the Depuy Synthes Attune artificial knee.

The Attune Artificial Knee

The DePuy Synthes Attune artificial knee is marketed as an “innovative, comprehensive, integrated knee system” that provides stability, strength, and a greater range of motion post-surgery. This novel design was created to be a better approach to traditional knee replacements. But many people have experienced complete failure of their Attune knees shockingly soon after surgery.

Knee InjuryThe Zimmer NexGen artificial knee has been causing patients much pain and suffering over the past decade. Zimmer first instituted a recall of one group of NexGen components in 2010, and there have been other recalls in the years following. Many patients with the NexGen knees have suffered pain and an inability to maintain normal physical activity. The lawsuits of course followed.

In August 2011, to handle the growing number of lawsuits over the NexGen knee, a multidistrict litigation (MDL) site was formed in Chicago, Illinois and assigned to federal district court judge Rebecca Pallmeyer. The MDL is titled: In Re: Zimmer NexGen Knee Implant Products Liability Litigation, No. 2272 (1:11-cv-5468).

Do You Qualify for the Zimmer NexGen MDL?

The overarching requirement to participate in the MDL is (1) to prove implantation of the Zimmer NexGen knee components (with product stickers from the original surgery), and (2) to show through the medical records clear evidence of loosening. Loosening is when the artificial knee components begin to move in the patient’s leg and separate from the bone. This is not good. Loosening can be very painful. A loose artificial knee will cause major complications and eventually require replacement and revision surgery. When a patient complains to an orthopedic surgeon about knee pain after a total knee arthroplasty, the doctor will order an X-ray. The doctor will look for radiolucent lines, which are spaces between the artificial knee component and the patient’s bone. Essentially, small gaps occur because the medical device is not implanted tightly or securely to the bone. These spaces can cause serious problems for a patient with an artificial knee, and can be the first signs of an artificial knee failure. The spaces often fill with fluid or tissue which can cause additional loosening of the medical device.

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Artificial Knee Failure

“The Most Anatomically Accurate Knee Implant”

In 2012, medical device manufacturer Zimmer, Inc. introduced the Persona artificial knee to the public with lofty language.  Zimmer announced that the company was “redefining knee arthroplasty and ushering in a new era of personalization with the introduction of the Persona Knee.” Zimmer stated on its website that by “working with more than 50 of the world’s most respected orthopaedic surgeons, and utilizing analytics from both genders and 1,500 different bone types from 26 different ethnicities, Zimmer was able to create the most anatomically accurate knee implant.”

The reported advantage of the Persona knee system, according to Zimmer, was that it would give surgeons several component options for each patient and each surgery, thus assuring a tailored fit for the patient.  Again, from Zimmer: “the result is an implant system that addresses the unique needs of the patient and accommodates surgeon-specific preferences — all while empowering surgeons to minimize “trade-offs” and better optimize results.”  Sounds great, doesn’t it?

Zimmer sold the Persona knee from November 2012 through March 2015.  A lot of them.  But bad things began to happen.  People began reporting pain and other symptoms, including loosening of the knee components inside the leg.

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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.
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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.
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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.
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