Zimmer High-Flex Knee Implants
Unhappy with the sales of their NexGen knee implant line, Zimmer Orthopaedics sought to design a “high-flex” knee device which would allow for more flexion than any other knee implant on the market. Zimmer developed the CR-Flex and LPS-Flex devices, which the company then aggressively promoted to orthopedic surgeons for use in younger, more active patients. Since 2003, more than 150,000 Zimmer NexGen CR and Zimmer NexGen CR-Flex Porous Femoral implants have been sold in the U.S.
The CR-Flex is a “high-flex” femoral implant. A femoral implant is a synthetic device used to cap the femur (the thigh bone) at the point where it connects to the tibia at the knee. It is made of porous fiber metal and a cobalt-chromium-molybdenum alloy and is attached to the femur without cement. In most knee replacement systems, a type of surgical cement is used to hold the implant in place. However, the Zimmer NexGen CR-Flex knee does not use cement. This design may increase the risk of a knee implant loosening and needing additional surgery to revise the implant.
Zimmer’s high-flex components theoretically allow patients to bend their knees by 155 degrees, while standard knee devices provide for up to 125 degrees of flexion. However, Zimmer’s design changes also resulted in greater stress being placed on the implant’s parts, particularly the femoral component, often leading to loosening of the device within only a few years of implantation. Numerous studies have determined that Zimmer’s high-flex devices have unacceptable failure rates.
In March 2010, at a conference of the American Academy of Orthopaedic Surgeons, several prominent knee surgeons presented data on the outcomes of 108 knee replacement patients who received the Zimmer NexGen CR-Flex Porous Femoral component at Rush University Medical Center in Chicago, Illinois. The data indicates that 36% of the CR-Flex implants were loose after two years, and 9.3% of the implants were either revised or scheduled to be revised because of looseness and associated pain.
According to a report in the Wall Street Journal, the authors of the study have previously presented their concerns to Zimmer Orthopaedics and called for a recall of Zimmer’s high-flex knee replacement products from the market.
Another study published in the Journal of Bone and Joint Surgery found that 38% of Zimmer’s high-flex knees failed within two years of implantation and that over half of implanted patients require a revision surgery.
In September 2010, product recalls were issued by the United States Food and Drug Administration for several Zimmer knee implant components. A Zimmer NexGen MIS recall was issued for more than 68,000 knee components following at least 114 reports of problems that caused some individuals to experiencing loosening of the parts or the need for additional knee surgery. In addition, a Zimmer NexGen LPS® recall was issued due to nonconfirming and inconsistent geometry.
Zimmer Knee Implant Litigation & Trial Update
Zimmer high-flex knee lawsuit cases filed in federal courts around the country have been consolidated in In Re: Zimmer NexGen Knee Implant Products Liability Litigation, MDL No. 2272 in the United States District Court for the Northern District of Illinois before the Honorable Rebecca Pallmeyer. As of April 2015, 1,402 cases are pending in the MDL No. 2272.
The first CR-Flex bellwether trial in the MDL is scheduled to begin on July 1, 2015.
Our firm represents a number of clients from Maine and the U.S. who have suffered aspetic loosening of their Zimmer high-flex knee devices leading to unnecessary revision procedures. We are actively litigating cases in the MDL. Although some components have been recalled from the market, Zimmer continues to sell its high-flex knee system and the devices remain in frequent use at many of Maine’s largest healthcare facilities.
If you or a loved one have suffered complications from a Zimmer knee implant, you may be entitled to pursue a claim against the manufacturers for damages. For a free and confidential case evaluation, please call our office toll-free at (888) 747-5342 or complete our online contact form and we will promptly respond to your inquiry.