Zimmer NexGen Knee Replacement
Each year, thousands of patients undergo total knee replacement (TKR) using devices produced by Zimmer, Inc., but now many who have received the products are filing lawsuits against the company. Hoping to relieve pain and achieve greater levels of flexibility and mobility, many of these same patients find themselves in greater pain, experiencing limited mobility, and facing revision surgery.
The Sanders Firm represents those who have been injured by various models within Zimmer’s NexGen line of products. We have been at the forefront of this litigation since the earliest adverse events were reported and have been closely monitoring various model recalls while tracking developments in the ongoing negotiations and the company’s growing settlement fund.
Introducing the Zimmer NexGen Flex line
Knee replacement devices have been used throughout the first half of the 20th century, gaining popularity in the 1970s. Zimmer introduced its Next Generation (NexGen) Complete Knee Solution system in 1994. This family of products gained FDA clearance in 1995 through a less comprehensive 510(k) process than previously released models due to it being “substantially equivalent” to devices already available on the market. The NexGen Knee Solutions systems were a success and positioned Zimmer competitively in the medical marketplace.
Seeking to further its edge in this market, Zimmer introduced a new line of NexGen “Flex” components in 2001. Some models in the Flex line included a number of innovations, such as cement-less technology and gender-specific design. However, studies comparing the standard and Flex versions of the CR, LPS, and LPS Gender models found that they provided little to no improvement in terms of functionality and range of motion. Plaintiffs represented by the Sanders firm in lawsuits against Zimmer, Inc. contend that they paid a high price for these “advanced” products with little proven benefit.
Dr. Berger’s ground-breaking report on high-flex design
More troubling were certain conclusions drawn by critics that the components of these medical devices were dangerous. Richard Berger, a consultant to Zimmer and himself an orthopedic surgeon at Chicago’s Rush University Medical Center rocked the company boat in 2006, informing his colleagues of his theory that the NexGen CR Flex Porous Femoral Components, which do not use cement, were coming loose after being implanted in some patients.
Berger and a colleague at Rush University, Craig Della Valle, presented the findings of their non-peer reviewed report at a meeting of the American Association of Orthopaedic Surgeons in 2008. According to the report, of the 108 CR-Flex recipients studied, 36% showed signs of radiographic loosening within 2 years of receiving their implant. Of that same pool, 8.3% had a knee revision surgery within the same time frame.
Other studies implicate different models of the NexGen Flex line. One published report appeared in The Bone & Joint Journal stated that 38% of the knees of patients fitted with the NexGen LPS Flex Total Knee system by one surgeon over a period of 18 months showed signs of loosening of the femoral component at the “mean follow-up” appointment (32 months), while 21% of the knees required surgical revision at the mean of 23 months.
Zimmer has consistently denied any such problems and has stood by its products’ worldwide safety and efficacy record.
Zimmer NexGen components recalled
FDA recalls of the Zimmer NexGen Knee components have been limited to specific models for very specific reasons. There has been no push to remove any model from market entirely. These Zimmer knee recalls are limited to a class 2 recall on Dec. 2, 2010 of the Zimmer NexGen Complete Knee Solution LPS Femoral Component and the Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component for “nonconforming internal CAM radius.” Another class 2 recall was announced on Sept. 13, 2010 with regard to the Nexgen Complete Knee Solution MIS Tibial Components, locking screw and stem extensions due to 114 instances of the devises loosening, requiring the patients to have additional surgery.
Health problems resulting from Zimmer knee devices
An artificial knee can fail if the implant loosens or fractures or if the joint is dislocated or unstable. The product liability lawyers of The Sanders Firm receive first hand accounts of the health problems facing our clients in the aftermath of this terrible condition.
Lawsuits against Zimmer contain allegations of:
- debilitating paint
- damage to surrounding tissues
- nerve damage
- bone loss or fracture
- unstable joints
- limited range of motion
- problems standing or walking
- blood clots
Multidistrict Litigation involving the Zimmer NexGen systems
Over 1000 patients have brought suit against Zimmer over their troubled line of knee replacement systems. These lawsuits have been consolidated as part of multidistrict litigation (No. 2722) against the company in the U.S. District Court for the North District of Illinois slated to begin in 2015. Multidistrict litigation (MDL) involves a streamlined process in which related lawsuits are presented in one central court. However, unlike a class action suit, each case will be heard individually on its own merits.
We welcome this development: whereas a class action lawsuit may involve a more limited settlement for the plaintiffs as a group, MDL is less likely to entail such limitations and will produce the best results for our clients.
Litigation has been filed with regard to the following NexGen models:
- NexGen Complete Knee Solution (LPS-Flex)
- NexGen Complete Knee Solution Gender Solutions Female LPS-Flex (GSF LPS-Flex)
- NexGen Complete Knee Solution Cruciate Retaining-Flex Femoral Components (CR-Flex)
- NexGen Complete Knee Solution CR-Flex Gender Solutions Female CR-Flex (GSF-Flex)
- All NexGen MIS Total Knee Procedure Stemmed Tibial Components
Compensation is available for your injury
Defective Zimmer knees have resulted in pain, suffering, and disability for thousands. If you have been injured by a Zimmer knee medical device, the Sanders Firm can help you get compensation from Zimmer, Inc. by filing a personal injury lawsuit on your behalf.
Reportedly, Zimmer has already set aside a settlement fund in excess of 150 million dollars for another lawsuit related to faulty hip implants. The first trials for the NexGen knee systems are set for 2015. The amount of compensation received through a Zimmer knee lawsuit will vary depending on the nature of your injury and which device was involved.
Please call The Sanders Firm at 1.888.660.3714 for a free evaluation of your potential claim. There is a never a charge for our legal fees unless we recover compensation on your behalf.
- FDA, Recall Information http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=92118&CREATE_DT=2010-09-13
- FDA,Recall Information http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=131&event_id=&productdescriptiontxt=zimmer¢erclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&productshortreasontxt=&firmlegalnam=&knumber=&pnumber=&pagenum=10&sortcolumn=cdd
- New York Times, Surgeon vs. Knee Maker: Who’s Rejecting Whom? http://www.nytimes.com/2010/06/20/business/20knee.html?pagewanted=all&_r=0
- Journal of Bone and Joint Surgery, High incidence of loosening of the femoral component in legacy posterior stabilized-flex total knee replacement http://www.bjj.boneandjoint.org.uk/content/89-B/11/1457.full.pdf
- Journal of Bone and Joint Surgery, Comparison of a Standard and a Gender-Specific Posterior Cruciate Substituting High-Flexion Knee Prosthesis: A Prospective, Randomized Short Term Outcome Study, http://jbjs.org/article.aspx?articleid=5699