Articles Tagged with Stryker

Published on:

Artificial Hip Joint Showing femoral head and femoral neck and stem

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:

Catalog Number Femoral Head Diameter Offset
6260-9-236 36mm +5
6260-9-240 40mm +4
6260-9-244 44mm +4
6260-9-340 40mm +8
6260-9-440 40mm +12
6260-9-344 44mm +8
6260-9-444 44mm +12

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

LFIT V40 Femoral Head

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: 919.546.8788.

 

Published on:

Artificial Hip System
The vast majority of artificial hip failures over the past decade involved metal-on-metal (MoM) hip components. These medical devices were meant to revolutionize the artificial hip market. Specifically, the all-metal hip components were intended to last a long time, and much longer than older generation artificial hips using materials like ceramics and plastics, which had a tendency to wear down and “fail” after twelve or fifteen years. Beyond that, the metal-on-metal artificial hips were touted to withstand the rigors of active, athletic patients. It sounded like a terrific advancement in the development of artificial hips. The problem is, the metal-on-metal design did not work, in many cases because the metal acetabular cup and the metal femoral head would grind together day after day, month after month, releasing harmful metal debris (metallosis) into the patient’s body. Far too many people were forced to get revision surgeries a few years after the implant surgery to remove the metal hips.

It turned out to be a disaster for thousands of patients and for several large medical device manufacturers. Depuy and Zimmer, to name just two companies, faced thousands of lawsuits from people injured by the metal-on-metal artificial hips. Many of those cases are resolved or resolving, but many more await settlement or jury trials.

The LFIT V40 Is a Metal-on-Polyethylene Artificial Hip

Published on:

Stryker LFIT V40 Artificial Hip MDL
We’ve previously blogged about Stryker LFIT V40 artificial hip problems, discussing a recall made back in August 2016 and how to tell if you have an artificial hip that’s part of that recall. Since those posts a lot has been going on in courthouses across the country, with dozens of lawsuits popping up from individuals who received affected artificial hips made by Striker Orthopaedics and its subsidiary, Howmedica Osteonics Corporation (HOC).

Just recently, approximately 33 pending lawsuits against HOC were consolidated into a multi-district litigation (MDL). In a way, you can think of this consolidation as a “things just got real” moment for HOC. But what’s the big deal about the Stryker LFIT V40 litigation now being in MDL status? Let’s begin by discussing the underlying lawsuits.

Why Are the Plaintiffs Suing?

Published on:

Patient with Artificial Hip Failure
Not all artificial hips fail. Many total hip replacement surgeries are successful. Unfortunately, the metal-on-metal artificial hips have “failed” at a rate much higher than previous artificial hips, 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.

In any hip replacement surgery, there is 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 dozens 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.

For many patients, however, particularly those who received the metal-on-metal hip, there may come a point when they wonder if their artificial hip has failed. But given that all hip surgeries initially come with some discomfort and pain, how do they know if their hip has failed.

Published on:

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:

Continue reading →

Published on:

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.

Continue reading →