For patients suffering from arthritis and other debilitating knee conditions, Zimmer, Inc. advertised its NexGen knee replacement products as a way to reclaim aspects of life — allowing for a renewed interest in hobbies that were lost due to knee problems or pain. In reality, the safety of many of Zimmer’s NexGen’s products has come into question, as studies have suggested NexGen knee replacements are loosening, often requiring painful revision surgery.

What You Can Do & How We Can Help

The Schmidt Firm, LLP is currently accepting Zimmer NexGen knee replacement induced injury cases in all 50 states. If you or somebody you know has been injured by a Zimmer NexGen knee replacement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Zimmer NexGen Knee Replacements: An Overview

Since 2003, Zimmer Inc. has sold over 150,000 NexGen Knee Replacement systems. The knee joint replacements are designed to renew the knee joint in patients with arthritis, dead bone or knee tissue, or a deformity of the knee. It offers an opportunity to regain knee movement for patients who have knee problems due to age, physical injury, low blood flow, dead or weakened bone tissue, or any physiological abnormalities.

Ideally, the knee implants should replace the painful part of the knee joint, allowing increased movement and restoring alignment.

Unfortunately, models of Zimmer’s NexGen knee replacements systems are failing pre-maturely and requiring patients to undergo painful corrective surgery. Parts of the system are loosening, causing adverse side effects in patients. Several models have even been recalled by the FDA. While the problem lies with the product, Zimmer is placing blame on the surgeons.

If you have ever experience a loosening of your Zimmer NexGen knee replacement and/or required corrective surgery as a result, you may want to contact a Zimmer NexGen knee lawyer at The Schmidt Firm, LLP for a free case evaluation to discuss the potential of a Zimmer NexGen lawsuit.

Defective Zimmer NexGen Models

The NexGen systems and products that may be defective include:

• Zimmer NexGen Complete Knee Solution MIS Tibial Components
• Zimmer NexGen CR-Flex Knee Replacement
• Zimmer NexGen CR-Flex Porous Femoral Component
• Zimmer NexGen LPS-Flex Mobile and Bearing Knee
• Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component
• Zimmer NexGen Complete Knee Solution LPS Femoral Component

NexGen Knee Replacement Side Effects and Symptoms

The following symptoms and side effects have been associated with a defective Zimmer NexGen Knee:

• Difficulty standing or walking
• Loosening of Zimmer replacement parts
• Revision surgery for a Zimmer knee
• Knee replacement failure
• Unexplained knee pain or discomfort after surgery
• Other knee complications

Zimmer NexGen Knee Replacement Study

As reported in a June 19, 2010 New York Times article, orthopedic surgeon Richard A. Berger — who performs upwards of 1,000 hip and knee replacement surgeries annually — used to work for Zimmer, designing surgical tools and joint products for the company.

However, several years ago, Berger warned Zimmer that one of its artificial knee systems, the NexGen CR-Flex was failing. Because Zimmer dismissed his warnings, Berger conducted a study, along with the assistance of another surgeon, and released it to the public.

The study suggests that the NexGen CR-Flex showed early signs of failure — requiring re-operation — in about 9 percent of the 100 patients studied. Typical failure rates are approximately 1 percent. Additionally, the knee replacement showed signs of being loose in about 36 percent of all patients.

Despite the evidence, Zimmer blamed Berger and other surgeon’s techniques, instead of re-evaluating their NexGen CR-Flex replacement knees.

Berger believed the NexGen replacement knees were defective because they did not require cement to bond the thigh bone to the femoral component of the device. Instead, it relied on the bone naturally fusing with the implant. However, Berger found this was not the case; the device’s looseness meant it had not fused completely.

FDA Zimmer NexGen Recalls

September 13, 2010 — The FDA issued a Class 2 recall of the NexGen Complete Knee Solution MIS Tibial Components. In the recall notice, the FDA stated there have been:

“Complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs (Medical Device Reports) filed, all reporting that the device loosened and the patient required additional surgery to replace the device.”

More than 68,000 of these products had previously been distributed.

Prior to the recall, Zimmer Inc. sent out an ”Urgent Device Correction” letter on April 26, 2010 to all customers describing the problem and instructing them to destroy all previous versions of the surgical technique, and to review the attached revised surgical technique, which instructed surgeons to cement and pressurize the tibial component.

December 2, 2010 — The FDA issued a Class 2 recall for the Zimmer NexGen Complete Knee Solution LPS Femoral Components. The recall was issued for several different sizes of the femoral component, citing problems with a “nonconforming internal CAM radius.” The recalled components include:

Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component

• Size E, left knee
• Size E, right knee
• Size F, right knee
• Size G, left knee

NexGen Complete Knee Solution LPS Femoral Component (n.k.a. LPS Option Femoral Component)

• Size E, right knee
• Size F, right knee
• Size F, left knee
• Size G, left knee
• Size G, right knee

Do I Have a Zimmer NexGen Knee Replacement Lawsuit?

The Schmidt Firm, LLP is currently accepting Zimmer NexGen knee replacement induced injury cases in all 50 states. If you or somebody you know has been injured by a Zimmer NexGen knee replacement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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