Recalls for Hip Replacement Devices

Role of the FDA, how it approves hip replacement devices

The FDA is in charge of approving medical devices like those used in hip replacement surgeries before they are offered to the general populace.

Each device is placed into one of three regulatory classes depending on how much control is necessary to ensure the device’s safety and effectiveness. Most hip replacements are Class II devices, which are “subject to special controls identified by the agency, which may include special labeling requirements, performance standards, and postmarket surveillance.” Many metal-on-metal implants, however, were bumped into Class III, which are those “for which insufficient information exists to determine that general or special controls are sufficient to provide a reasonable assurance of safety and effectiveness.”

Devices generally go through a pre-market notification and approval process before being sold. The notification process is called 510(k); if the FDA believes that the device submitted is substantially similar to a device that’s already on the market, it might not require the approval process and the manufacturer can market the product without further trouble. If it hasn’t been approved yet, the FDA will most likely require valid scientific evidence in order to make its determination.

Voluntary vs. mandatory recalls

If a device is not performing as expected, a manufacturer can choose to remove it from the market themselves (far more common) or wait until the FDA gets enough complaints to do it themselves.

It is very expensive for the FDA to do a recall of medical devices like those used in hip replacement surgeries, which is probably why they have only done three in a 10-year period (1993-2003). When companies do it themselves, they can recall for any reason – marketing defects, patient complaints, insufficient instructions for surgeons and more.

What happens during a hip replacement recall?

Unfortunately, there is no national registry for recalls, though there is a recalls website created and maintained by the federal government. There is no single agency devoted to recalls and instead recalls of hip replacement devices and other recalls are handled by four different agencies: the FDA, the United States Department of Agriculture, the National Highway Traffic Safety Administration, and the Consumer Product Safety Commission. Each handles a different type of product. The FDA and the USDA cover most type of food, drugs and medical-grade devices; the NHTSA covers vehicles; and the CPSC, which has a very wide mandate, covers things like toys or wearables.

Since a hip implant isn’t a piece of furniture you can toss out with the garbage, patients will likely have a difficult time knowing A) their specific hip implant is subject to a recall, and B) whether they need to have it removed from their respective bodies.

FDA recalls are triggered by specific instances:

• A company discovers there is a problem with their product and contacts the FDA
• An FDA inspection of a facility identifies an issue and prompts the recall
• The FDA learns about issues from other reporting agencies or patient complaints

The problem is that manufacturers don’t keep track of which patient has which hip implant. The United States has no consumer-facing national registry, like that used in England and Wales. So, you likely won’t know what’s even been implanted during your hip surgery unless your doctor specifically told you, “I am implanting you with a Stryker ABG II device.” Manufacturers depend on doctors informing their patients, so once they have sent out a recall notice, they hope for the best. We hope we will see better tracking of hip replacement and other medical devices with the American Joint Replacement Registry’s efforts.

If a hip replacement device is recalled, does that mean it’s off the market immediately and there’s no chance my doctor used it in my hip replacement surgery?

When a device has been recalled, it doesn’t necessarily mean you have to rip it out of your body. It just means that the manufacturer has identified issues with its product. It could be anything from insufficient instructions to device failure, but until you check the notice, your doctor might still find the product usable. Your surgeon will discuss whether your implant should be removed and what the risks of doing so are.

 Call your doctor – your surgeon can help

You likely won’t know the model of implant that was used. Why would you? It’s not like you’re going to be quizzed on it. However, this information will be in your medical records, and you can call your doctor to ask. He or she might not be able to tell you if it’s been the subject of a recall, but you can at least get the model and search online yourself. If it hasn’t been subject to a recall, you can set up a Google alert or something comparable. That way, if your model is mentioned online at all, you will receive a notification. (How to set up a Google Alert.)

 Is there a governing body that lists all the hip replacement recalls?

There is no single governing body for product recalls; it’s a mishmash of four different overseeing entities. The FDA would be the governing body for medical devices, and their information is updated constantly at this website.

Corin hip replacement recalls

• Cormet 2000

Depuy Orthopedics hip replacement recalls

• ASR
• ASR XL
• AML
• Pinnacle
• Prodigy
• S-ROM
• Marathon

Centerpulse hip replacement recalls

• Orthadapt
• Inter-Op

Encore Orthopedics hip replacement recalls

• Foundation
• Linear
• Revelation

Biomet hip replacement recalls

• M2a
• Mallory-Head
• Taperloc

Exactech hip replacement recalls

• Opteon

Zimmer Holdings hip replacement recalls

• Durom Cop
• VerSys
• Mayo Hip
• Longevity

Stryker Orthopedics hip replacement recalls

• Rejuvenate
• ABG II
• Omnifit
• Sulzer Inter-Op
• Exeter
• Crossfire
• Trident Hemispherical SH

Wright Medical Technology hip replacement recalls

• Conserve Plus
• Profemur Z
• Perfecta
• Dynasty
• Metal Transcend

Smith & Nephew hip replacement recalls

• Metal liner of R3
• Duo
• IVS Tunneler
• Modular SMF
• Modular Redapt Femoral System
• TriGen Hip Nail
• Synergy
• Birmingham

Common symptoms of failing hip implants

Hip implants are supposed to last, on average, about 15-20 years. Many of the metal models had to be replaced after only a few years because they led to significant health issues. The metal surfaces on the ball-and-socket joint causes high friction rates, making the implant wear down faster. This friction can cause metallosis, which – if not treated – can lead to:

There is also a condition called “osteolysis,” which is inflammation that causes the device to loosen from the socket. Patients will most likely have to receive a corrective surgery, which means they will have their metal parts removed and replaced with safer models. Additional surgeries mean additional risks, as well as recovering again from what should’ve only taken place once. This means more physical therapy, more time off work, and more money lost.

See more on complications after hip replacement surgery.

Is there any kind of warranty for a hip replacement?

As Consumer Reports noted, hip implants should have some kind of lemon law. What that means is if you bought a car that broke down because of a defect, the manufacturer – not the buyer – should foot the bill to fix it. Hip implants have no such law, and patients are expected to pay for revision surgeries.

What are my options?

Medically-speaking, your options are to suffer with the implant or to have it revised, removed or replaced. Legally-speaking, you can decide to pursue a case against either the manufacturer or the surgeon who implanted it. If your doctor did not implant it correctly, that could mean a case for medical malpractice. If the implant is defective and causing adverse health effects, that could be a defective products case. There are currently thousands of cases pending against manufacturers, and there will likely be a class-action, mass tort or multi-district litigation that you can join.

Learn more about hip replacement lawsuits.

Do I have to decide now? What if I want to wait to see if my hip replacement recall symptoms worsen?

You should decide as quickly as possible. Many states (though not every state does) follow the discovery rule, meaning that as soon as you know there is a problem, the clock on your case starts to tick. You don’t want the statute of limitations to run out and bar you from filing a claim. There is only so much time to file your case depending on where you live, and you don’t want to lose the ability to file.

Would any harm come to my doctor?

If the implant was defective and your doctor did not know it at the time, your doctor will likely be fine. However, if your surgeon knowingly implanted a defective device, that is something else entirely. What matters is what he knew and when he knew it. Additionally, if he implanted the device incorrectly, which led to your health issues, he will have to answer for that. However, if it was just the device that was defective, your doctor will emerge unscathed.

For medical malpractice, there are often pre-filing requirements, such as sending notice to the doctor in question and providing a letter from a certified medical professional that details your injuries. If you don’t fulfil these requirements, your case might be tossed out.

Read more and see where to find a lawyer in How to Find the Right Medical Malpractice Attorney for Your Case. Consider also checking out the Enjuris law firm directory to find your perfect legal match.