Knee Replacement Surgery

Knee Replacement Overview

Knee replacement surgery is performed to alleviate pain and restore function in a damaged knee. During the procedure, a surgeon removes a damaged or diseased knee joint and puts an artificial implant in its place.

Another name for knee replacement surgery is total knee arthroplasty (TKA). Knee replacement is often an inpatient procedure. ^{(3) (4)}

What Makes Someone Require a Knee Replacement?

Most people who receive knee replacement surgery have arthritis. But injury, other diseases, or simply years of use can also damage the knee. ⁽⁵⁾

Your doctor may recommend knee replacement surgery if: ⁽⁶⁾

• Your knee pain prevents you from sleeping.
• Your knee pain prevents you from doing everyday activities such as walking.
• Your knee pain prevents you from taking care of yourself.
• Other treatments have failed to reduce your knee pain.

Who Typically Gets Knee Replacements?

More than 98% of patients who undergo total knee replacement surgery are 45 or older. The procedure is most common for people 65 and older. However, younger people make up an increasing percentage of knee replacement patients. ^{(7) (8)}

The average age for knee replacement patients dropped significantly from 2000 to 2010. ⁽⁹⁾ Knee replacement surgeries performed on people aged 45-64 tripled from 1999 to 2008. ⁽¹⁰⁾

Most knee replacements only last a decade or two before wearing out. This means these younger knee replacement patients are likely to “outlive” their devices and will eventually require revision surgery to replace them.

How Many Knee Replacements Are Done Each Year?

More than 750,000 people had knee replacement surgery in 2014 according to data from the Healthcare Cost and Utilization Project. ⁽¹¹⁾ Researchers project the number of knee replacement procedures will increase to 1.26 million by 2030 as baby boomers continue to age. ⁽¹²⁾

Knee Replacement Recalls

Eager to meet the rapidly growing demand for knee replacements, medical device manufacturers have sold knee implants without first adequately testing their safety.

The U.S. Food and Drug Administration (FDA) has a 501(k) Program that allows companies to promote new medical devices if they can prove the device is “substantially equivalent” to a device already on the market. ⁽¹³⁾ As a result, new devices can gain approval and be sold to the public without first undergoing clinical trials.

Because of this approval process a dangerous flaw may not reveal itself until after a device has been implanted inside the bodies of thousands of consumers.

When Do Companies Recall an Implant?

When a company discovers a problem with a device, it needs to issue a recall. According to the FDA, “recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.” ⁽¹⁴⁾

Manufacturers have issued recalls for a number of knee replacement devices, including:

• Arthrex iBalance Total Knee Arthroplasty ⁽¹⁵⁾
• Smith & Nephew Journey BCS Knee Replacement ^{(16) (17)}

In 2015 and 2016, Arthrex, Inc. instituted recalls of the iBalance tibial tray because of tibial baseplate loosening. The trays were manufactured with a smooth surface that may have resulted in poor bonding between the tray and the knee. ⁽¹⁸⁾

Five years after stopping production, Smith & Nephew issued a recall of its first-generation Journey BCS Knee in 2018. The manufacturer cited “a revision rate over 1.5 times” the average as the reason for the recall. ^{(19) (20)}

FDA Class 2 Recalls

All of these recalls were categorized as Class 2 by the FDA. Class 2 means a product “may cause a temporary or reversible health problem” or has a slight chance of causing “serious health problems or death” ⁽²¹⁾

The FDA medical device recall database contains the most up-to-date information about recalls of knee implants and other devices.

Lawsuit Allegations

Unfortunately, some people experience severe health problems following knee replacement surgery. ABC News reported on a woman whose knee implant left her in “constant pain, 24/7,” and too disabled to work. ⁽²²⁾ She’s not alone: an estimated one-third of patients with knee replacements continue to experience chronic pain following the procedure. ⁽²³⁾

What Symptoms Are People Experiencing from Knee Replacements?

People suffering from failed knee implants may experience these symptoms:

• Pain.
• Swelling.
• Instability.
• Loss of range of motion.
• Inability to walk.

Failed knee implants often require revision surgery. Revision surgeries carry greater risk than primary surgery. They are more likely to have complications. ⁽²⁴⁾

Knee Replacement Revision Surgery

Revision surgeries are expensive. The average cost of revision surgery is nearly $50,000. ⁽²⁵⁾

Revisions surgeries are also more likely to result in extended hospitalization. ⁽²⁶⁾ The average hospital stay for a knee revision is slightly more than 5 days. ⁽²⁷⁾ Revisions also require follow-up care and physical therapy.

What Injuries or Health Problems Are People Suing For?

Many knee implant patients who had to undergo revision surgery because their devices prematurely failed due to loosening or breakage have filed lawsuits against the device manufacturers.

Reasons for revision surgery include: ^{(28) (29)}

• Mechanical loosening.
• Implant failure/breakage.
• Bone fracture and osteolysis (bone tissue loss).

If you have been harmed by a faulty knee implant, you may be able to receive compensation for your medical expenses as well as for your pain and suffering. If the complications required you to miss work for medical treatments or left you unable to work due to a disability, you may also be entitled to compensation for lost wages.

Settlement Amounts

Weitz & Luxenberg’s Defective Drugs and Medical Devices Litigation Unit has represented thousands of patients harmed by defective orthopedic devices.

Ellen Relkin, co-chair of the team, has served in court-appointed leadership roles in multiple large hip implant litigations:

• As co-lead counsel, Ms. Relkin helped negotiate a $2.5 billion settlement for patients harmed by defective DePuy ASR hip implants. The standard base payment for patients enrolled in the settlement was $250,000. This amount was separate from reimbursements made to Medicare and other health insurers to cover revision surgeries and associated care.
• As lead and liaison counsel, Ms. Relkin worked to negotiate a $1 billion settlement for patients harmed by recalled Stryker Rejuvenate and ABG II hip implants. The base award was $300,000 per failed implant. Additional compensation was provided to patients who suffered greater complications.
• Ms. Relkin was also one of two court-appointed members of the settlement oversight committee for the recalled Stryker LFIT Femoral Head. A confidential private settlement with Stryker was announced in late 2018.

Who Should Be Filing a Lawsuit?

You may want to consider filing a lawsuit if you had a knee replacement and then:

• You needed to have revision surgery to correct a defective knee implant.
• Your doctor has told you that you will need revision surgery in the future but you are not able to have the procedure due to medical reasons.
• You experienced severe medical complications with your knee implant, especially complications related to premature loosening and other forms of implant failure.

Tips for People Who Are Filing Lawsuits

Some tips if you are considering filing a lawsuit:

• Don’t delay! The law limits the time you have to file a lawsuit, and the deadline varies from state to state. Speak with an attorney as soon as possible so you can file before the statute of limitations closes.
• Consult an attorney before participating in a manufacturer recall. Some recalls require you to waive your right to participate in a lawsuit, which would prevent you from receiving compensation.
• If you have not yet had your revision surgery, make arrangements with an attorney to have the explanted device and tissue samples properly stored as evidence.
• Gather all your medical and pharmaceutical records in one place.

How Can W&L Help You?

Consulting with an attorney experienced in handling lawsuits for defective medical devices can help you understand your options. Weitz & Luxenberg’s Defective Drugs and Medical Devices Litigation Unit has both the experience and the resources to handle complex litigations against powerful corporations.

The general public should not be test subjects for unproven new devices. We believe companies who rush unsafe products to the market should be held accountable.

It would be our privilege to help you obtain justice for the injuries you’ve suffered.