Articles Tagged with recall

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Woman waiting for Depuy ASR revision surgery
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

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Zimmer Biomet Reverse Shoulder Product Recall

Shoulder replacement surgeries are common and provide relief to thousands. But some conventional shoulder replacement surgeries don’t work, requiring a different type of shoulder replacement surgery.

In a typical shoulder replacement, artificial components replace natural ones, such that an artificial cup is placed into the shoulder while an artificial ball is placed at the top of the humerus, or arm bone. For individuals with rotator cuff tears and arthropathy, which is a complex type of shoulder arthritis, this type of shoulder replacement surgery doesn’t work.

Instead, patients must obtain a reverse shoulder replacement, which places the ball in the shoulder and the cup at the top of the humerus. One such reverse shoulder replacement medical device is Zimmer Biomet’s Comprehensive Reverse Shoulder System. However, this product has recently been recalled by Zimmer Biomet.

The Reverse Shoulder Recall

Zimmer Biomet Reverse Shoulder RecallOn December 15, 2016, Zimmer Biomet recalled its Comprehensive Reverse Shoulder System, noting that it was fracturing far more often than expected and could lead to serious problems, such as infection, inability to use the shoulder and even death. Fracturing is an unusual problem, since most shoulder replacement complications do not involve fracturing, but instead deal with excessive wear, dislocating and loosening of joint components.

Due to the severity of the problem with the Comprehensive Reverse Shoulder System, the U.S. Food Drug and Administration (FDA) classified this recall as a Class I recall, which is the most serious type of recall available.

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Orthopedic Surgeon with X-Ray of Stryker LFIT V40 Femoral Head

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:

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Total hip replacements are becoming more popular. Between 2000 and 2010, the number of individuals aged 45 years and older receiving total hip replacements more than doubled, rising from 138,700 to 310,800. One of the reasons for the increase is a result of medical and technological advancements in hip replacement surgery and artificial hip components.

Patient with Stryker LFIT Artificial Hip

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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