The Zimmer NexGen knee implant is an artificial knee designed to allow increased flexibility in the knee joint. The knee implant comes in a regular version and a "high-flex" version, which was marketed to allow for a greater range of motion. An added option with the NexGen system is the Tibial "minimally invasive solution" implant, or MIS Tibial, which attaches to the leg bone without the use of cement.
Zimmer promoted the MIS as reliably requiring less surgery after implantation. However, both the high-flex NexGen implants and the MIS NexGen Tibial implants have been found to fail at far higher rates than advertised.
FAILURE OF "HIGH FLEX" NEXGEN KNEE IMPLANTS
On June 19, 2010 the New York Times unveiled an exposé detailing a high rate of failure among components making up the Zimmer NexGen knee implant devices, used in hundreds of thousands of knee replacement surgeries worldwide.
The Times article reported on the findings of a former Zimmer consultant, Dr. Richard A. Berger. During his time with Zimmer, Dr. Berger raised concerns with the company several years earlier about the high failure rate of its NexGen knee implants that were designed to create increased flexion of the knee, beyond the normal range of flexion (known as high-flex knee implants). In March 2010, at the American Association of Orthopedic Surgeons, Dr. Berger reported that Zimmer's NexGen high-flex knees had a failure rate of 9 percent and exhibited signs of looseness in about half of the 100 patients studied.
FAILURE OF "MINIMALLY INVASIVE" TIBIAL NEXGEN KNEE IMPLANTS
A strong emphasis of Zimmer's marketing of the Zimmer NexGen Knee was the allure of the "minimally invasive" surgery. Zimmer even went to the extensive effort to trademark the term "MIS" or "Minimally Invasive Solutions." At the time, Zimmer promoted to patients and doctors that the "MIS" surgery would allow for smaller incisions, reduced blood loss and enabled shorter hospital stays.
However, in April 2010, Zimmer sent an "Urgent Field Safety Notice"/"Urgent Device Correction" letter to all customers using the Zimmer NexGen MIS Tibial. Zimmer made significant changes to the instruction manual and now required the use of a drop down stem that would help stabilize the tibial component. The claims of "less invasive" and "shorter hospital stays" proved to be faulty. Zimmer admits that surgically, "MIS procedures are inherently challenging and can involve reduced visibility, which may lead to difficulty with achieving proper implant alignment and cement fixation." On September 13, 2010, the FDA classified Zimmer's NexGen MIS Tibial components as a Class II Recall.
INJURIES FROM NEX-GEN KNEE IMPLANTS
Failure of the NexGen knee implant results in a loosening of the artificial knee from the bones in the leg, causing:
- Knee stiffness, pain, and swelling;
- Difficulty walking;
- Surgery to install a new artificial knee; and
- Surgical infection.
If you have suffered injury due to the failure of a Zimmer, Inc. NexGen knee implant, you may be entitled to compensation. Please contact the products liability attorneys at Aaron M. Levine & Associates for a free case evaluation.
