Zimmer Nexgen Knee

Zimmer developed its first knee replacement system in 1968 and today the company controls an estimated 26 percent of the knee-replacement market. Although Zimmer has long had a commanding market share, the company made modifications in 2001 to its popular NexGen Complete Knee Solution System, which was first released in 1995. The new line of replacement models, called the NexGen Flex system, was supposed to achieve a heretofore unheard-of level of flexibility, with 155 degrees of flexion.

Unfortunately, the NexGen Flex line of products not only failed to live up to the promises, it also began to cause serious adverse complications for patients. Two recalls occurred in 2010 affecting NexGen products and continue the company’s string of releasing risky medical devices. An unrelated Zimmer knee replacement device called the Natural-Knee II Durasul All Poly-Patella, was also the subject of a Class II recall by the FDA in January of 2012. These recalled products caused many patients to suffer serious adverse consequences. An experienced Boston defective knee replacement lawyer should be consulted if you or a loved one has experienced problems with any Zimmer knee replacement solution.

Zimmer’s NexGen line includes multiple offerings in the high-flex device market. Products marketed to patients seeking the added flexibility Zimmer promised to provide included:

• The NexGen Lateral Posterior Stabilizing (LPS) Flex-Fixed Bearing Knee (Released 2001).
• The NexGen Cruciate Retaining Knee (CR-Flex) (Released 2003)
• The NexGen Lateral Posterior Stabilization Mobile knee (LPS-Flex) (Released 2007)
• NexGen Minimally Invasive Solutions (MIS)
• NexGen Tibial components

In the 2000’s, Zimmer used special FDA rules to bring many of its products to the market, including the LPS-Flex knee replacement solutions. The rules are called 501(K) rules and they allow a manufacturer to do minimal testing before gaining approval of medical devices that are substantially similar to others that have already been approved.

Unfortunately, once the Zimmer products actually started to be used by patients, it became clear that there were serious problems, which were confirmed by independent researchers after the product’s release. For example:

• A 2007 study of patients who used the LPS Flex System showed that the femur replacement component loosened in 38 percent of patients after two years. While most knee replacements should last for between 15 and 20 years, the study in Journal of Bone and Joint Surgery reported that around 56 percent of patients in the study needed a revision surgery because of serious pain caused by the Zimmer knee replacement systems.
• A 2010 study of 166 patients who used the LPS Flex system showed that 30 of the patients experienced loosening of femur replacement components. Patients experienced a lack of stability in the knee, fractures and other complications.
• A March 2010 study in the American Academy of Orthopedic Surgeons reported that 8.3 percent of 108 patients required a revision surgery and 39 percent of patients showed loosening of the replacement knee components.
• A 2012 Mayo Clinic study demonstrated that a knee replacement failed in 3.9 percent of patients who had knee implants performed from 2000 to 2011. In 80 percent of cases, the knee implant loosened due to de-bonding.

These are just a few examples of research that revealed the Zimmer products were dangerous. Some of the complications researchers identified and patients experienced included:

• Severe knee pain.
• A limited range of motion (Almost one out of five patients with a Zimmer NexGen Flex knee couldn’t sit on their hands, squat or kneel as Zimmer had promised they’d be able to do).
• Loosening of the components of the replacement joint, especially in the femur.

Faced with mounting complaints, Zimmer notified surgeons about problems with some of its products, such as the NexGen MIS Tibial Component, in 2010. The FDA classified Zimmer’s communication with doctors as a Class II Recall. This was one of three FDA recalls prompted by problems with Zimmer devices.

If you or a loved one has experienced problems with a Zimmer knee replacement system, you may have certain legal rights. More than 700 lawsuits have already been filed against Zimmer for allegedly misleading the public, failing to warn of the risks of its product, negligent design, and design defects. Many claims are being consolidated into multi-district litigations, and you should speak with an experienced Zimmer NexGen knee replacement lawyer at the Jeffrey Glassman Injury Lawyers to determine if you have a claim and if you should join an MDL or pursue other legal options to recover compensation.

References:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm074823.htm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95540

http://www.nytimes.com/2010/06/20/business/20knee.html?_r=0

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=92118&CREATE_DT=2010-09-13

http://www.zimmer.com/content/pdf/en-GB/Zimmer_NexGen_CR-Flex_Mobile_Bearing_Implant_(09_2007)_(Not_available_in_the_US_or_Canada).pdf

http://www.bjj.boneandjoint.org.uk/content/90-B/10/1304.abstract

http://orthoinfo.aaos.org/topic.cfm?topic=A00510

http://www.mayoclinic.com/health/knee-replacement/MY00091/DSECTION=risks