Long-Term Medical Complications

More than a million Americans undergo hip and knee replacement surgery annually – a figure expected to quadruple by 2030 thanks to aggressive marketing materials targeting both aging baby boomers and younger consumers.

It’s expected by that time more than half of patients will be under the age of 65. The younger the patient, the longer the implant has to last.

Unfortunately, our Boston joint replacement lawyers at Jeffrey Glassman Injury Lawyers know manufacturers haven’t had a good track record in this regard.

Consumer Reports’ Safe Patient Project indicated that among the top six manufacturers of hip replacements, there were recalls of 578 hip implants or hip implant components between 2003 and 2013. Those same six companies initiated 709 recalls on knee implant devices or components in that same time frame.

As doctors with Brigham and Women’s Hospital Department of Orthopaedic Surgery noted in one study, hip and knee replacements first became common in the 1960s and early 1970s. At that time, research focused mostly on reducing rates of perioperative complications, such as infections and early technical failures. Focus gradually shifted to fine-tuning the surgical technique to help reduce pain and improve the functional results. But now, research is heavily focused on long-term outcomes. Specifically, there is great concern over implant failure. These devices have proven to fail often due to mechanical loosening, component fractures and breakdown of materials.

This can result in a host of medical problems, including:

• Joint instability
• Joint dislocation
• Joint stiffness
• Nerve damage
• Swelling and joint pain
• Broken bones
• Chronic pain
• Extensor mechanism disruption (knee)
• Patella tracking problems (knee)
• Formation of cysts or pseudotumors
• Osteolysis (hip)
• Metallosis (chromium or cobalt poisoning)

In a significant number of cases, revision surgery is necessary, and is often accompanied by extensive physical therapy and long-term use of pain medications. Worse, doctors say revision surgery – particularly to correct a loose implant – is often more difficult and tends to take longer to perform than initial replacement. Sometimes, multiple surgeries are necessary. Of course, each procedure carries with it a risk of certain complications, ranging from anesthesia problems to post-operative infections. These can be exacerbated if the patient is older or has other chronic health or immune issues.

Anytime a recall of a medical device is initiated, it is categorized into one of the U.S. Food & Drug Administration’s (FDA) three classes.

• Class I - A situation in which there is a reasonable probability that use of or exposure to product will result in serious adverse health consequences or even death.
• Class II – A situation in which the product may cause temporary or medically reversible negative health effects or where there chances of serious negative health consequences are remote.
• Class III - A situation in which the product is not likely to cause adverse health consequences.

In cases involving defective or dangerous joint replacement implants or components, the FDA typically issues a “medical device safety alert,” where there is an indication of unreasonable risk of substantial harm. In some situations, these are also considered “recalls.”

Of the 1,287 hip and knee replacement recalls that took place between 2003 and 2013, a total of five were deemed Class I. The vast majority – 1,198 – were labeled Class II. The remaining 26 were Class III.

These recalls involved the following manufacturers:

• Biomet
• DePuy
• Smith & Nephew
• Stryker
• Wright
• Zimmer

When a knee or hip implant fails by not performing as designed, patients suffer painful and unnecessary complications.

There are an unusually large number of knee and hip replacement failures because many manufacturers are able to push their products onto the market without proper testing through the FDA’s 510(k) premarket program. So long as a manufacturer can show the product is similar to something already on the market, the product won’t need to undergo clinical testing.

Some of the problems identified have included:

• Loosening of the device components
• Fracture of the device components
• Component misalignment
• Component breakdown
• Bone Fracture

Again, most of these will require revision surgery – sometimes multiple surgeries – to correct the problem. Patients may still be left with lifelong complications or disabilities.

Loosening of the device and metallosis are two of the most serious complications.

Loosening is usually the result of the device wearing out prematurely or the fact the cement used in the procedure fails to hold it in place. However, it could also be the result of metallosis.

Metallosis is a condition resulting from buildup of metallic debris (usually cobalt or chromium) in the soft tissue of the body. It’s most common with metal-on-metal hip replacements, where the metal ball grinds against the metal cup as the patient walks. Metal particles can be released into the bloodstream and result in toxicity. It can lead to the deterioration and death of surrounding tissue, and may also result in long-term nerve damage and even neurological problems.

If you are concerned that you may be suffering long-term complications as a result of a defective hip implant or defective knee implant, contact our Boston injury attorneys today to learn more about how we can help.