There have been a disturbing number of knee replacement recalls since the 2000s. In some cases, systems have been known to rot inside the body, requiring more surgery to have them removed. In other cases, a medical device, although faulty, cannot be removed due to its integration into the body.
Knee replacements are important. They are the fulcrums that are responsible for mobility, but they are also crucial to the overall structure of the body. When they go bad, everything else suffers. Bad knee devices can affect posture and walking, and damage other areas of the body in the process. Even if standing and mobility aren’t an issue, poor joint devices can cause pain in the very areas they are meant to help.
There are a number of reasons why a new knee needs to be recalled. All of them are due to faulty design, incomplete testing, or unexpected wear.
Faulty design refers to the device being poorly made to begin with. Perhaps it doesn’t bend as far as it should, or it bends in the wrong direction. The device itself could be badly held together, and some have even been known to have pieces fall off into the surgical site while being installed.
Sometimes knees replacements don’t fit properly. They aren’t designed with correct body proportions, and surgeons can even break them when trying to make them fit.
Shoddy knee replacements can go loose over time. For example, if the company didn’t do any long-term testing, they wouldn’t be aware that the tightness of the joint doesn’t hold long term. This causes patients to be stuck with sliding, detached knees in their legs. Related to this are knees that wear down over time. Once again, the product was likely rushed out, and no one was aware that the joints would slowly deteriorate, leading to loose knees.
Sometimes the product itself is okay, but its packaging is poor. During shipping, the device is damaged or exposed, making it unsterile.
One of the more absurd reasons for a recall is mixing up parts. Left-shaped components are mingled with right-shaped components. This makes devices difficult to install, since surgeons get confused about which piece goes where. This could also lead to a great deal of pain and mobility problems when installed, since the body is using artificial bones that are shaped in the wrong direction.
In roughly the last 20 years, three companies have been responsible for the majority of knee replacement recalls.
One of the biggest offenders of faulty knee tech is DePuy. Since 2003, they have had over 477 separate recalls on record., with the most recent in 2017. This number reflects 477 separate brands of devices and tools, not the total number of individual pieces that were recalled. What’s more, it isn’t just the devices themselves that have been recalled. In 2015, DePuy recalled a staggering number of tools related to their knee devices, almost 14,000 in total.
Zimmer Biomet is the biggest knee replacement company on the globe. It has had 377 separate recalls since 2003, and, again, this number reflects separate brands being recalled, not the number of individual pieces that were pulled off the market. Like DePuy, Zimmer Biomet had a big recall in 2017. Over 28,000 individual joint components were sent back due to their toxicity.
Stryker’s recalls are less worrying than the other two companies, but it is still worth being skeptical of their product. Going back to 2003, 125 of their products had to be recalled.
They did earn a bit of favor when they voluntarily recalled one of their products, the ShapeMatch Cutting Guides, which was meant to give surgeons a precise size and shape for cutting bone to install the artificial knee. It didn’t work. Injuries and pain were reported to the FDA, and Skyler pulled the product. Even after that debacle, Skyler found themselves implementing two more recalls a few years later.
Before agreeing to have anything implanted, make sure to research the product and the company. Avoid using products from companies with a long track-record of recalls or lawsuits against them. If the doctor is aggressive about that product and can’t or won’t use another brand, find another doctor.
If the insurance company won’t approve a device from another company, seek other options. There may be discounts or payment assistance programs available with other brands. Do not act out of desperation. However bad the current discomfort may be, it’s not worth the potential damage of implanting something that will have an even worse, damaging effect later.
As stated above, knees make up a big part of the overall structure of the body. Poor support in the legs leads to strain on other areas of the body. Constantly shifting weight to avoid pain becomes a problem. Favoring any one part of the body to avoid discomfort leads to damage somewhere else.
Infection is a huge concern for bad joint replacement devices. If a device starts to rot or go rusty, that can spread to the surrounding tissue. Now the patient has a potentially life-threatening problem. The inside of their leg is black with infection, and that tissue needs to be treated. If antibiotics aren’t enough to do the trick, surgeons may need to start removing portions of the leg tissue to save someone’s life. At its most extreme, infection could require an amputation.
Bad knee devices can lead to blood clots in the lower legs, a dangerous area. When blood clots dislodge, they travel up the arteries and create deadly blockages in the heart, lungs, or brain. A loose, untreated blood clot is deadly.
Surrounding bone may be in danger when a device is faulty. Depending on the nature and the location of the malfunction, bone connected to the device can break, fracture, splinter, or wear down.
Unlike a car, a medical device recall – particularly for a device that has been implanted in the body – doesn’t mean that the company takes back the device and pays for a replacement. Right now, there isn’t much of a direct plan in place when a medical device malfunctions. Patients are stuck with whatever is inside of them the same as if it were their body parts. From there, the patient must decide if living with the pain is worth it.
A device that has failed so spectacularly that it starts to cause other medical issues – like a rotting joint poisoning the body – has to be treated like any other medical problem. This is to say that a person would need to see a doctor, who recommends a surgery. The surgery is scheduled, and the device is removed or replaced. Any extra damage caused by the device is treated in whatever way necessary. The patient, along with their insurance, then pays the medical bills.
This is why a good lawyer is so important. The patient is the last person in the chain of the manufacture, distribution, recommendation, and implantation of a medical device. They should be able to trust that all necessary testing and approvals have been conducted on this device. It’s not their job or their problem to decide what is ready for public use.
Lawyers are needed to recover the cost of a failed medical device. They have the expertise to go after the responsible parties for medical bills and pain-and-suffering compensation. If replacing or removing the device is unfeasible, a lawyer may be able to get a large, lifelong settlement to ease the burden when related medical issues arise.
We are here to help if you or a loved one has suffered complications from a medical device. Call today at (850) 764-0383 or contact us online for a free consultation at no risk to you.