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Zimmer NexGen CR-Flex KNEE REPLACEMENT FAQ

What is a Zimmer NexGen Knee?

The Zimmer NexGen Knee Replacement is an implantable knee replacement system. In 2003 Zimmer Holdings, a leading designer, developer, manufacturer, and marketer of orthopedic devices and other medical devices, introduced the NexGen CR-Flex Fixed Bearing Knee. This Zimmer NexGen Knee is a synthetic device used to cap the thigh bone (femur) where it connects with the tibia at the knee.

Zimmer developed two different versions of the NexGen CR-Flex: a cemented version (that uses an adhesive to connect the thigh bone to the device) and a cementless version (which bonds by natural bone ingrowth).

The cementless Zimmer knee was designed to offer greater flexion than other knee implants because, unlike traditional knee implants, the NexGen CR is made of a high-flex porous femoral component and is not attached using cement.

Why is the NexGen CR-Flex defective?

Both versions of the Zimmer NexGen artificial knees are supposed to last at least 15 years, but a number of orthopedic surgeons, including former consultants for Zimmer, believe the cementless device is defective. Since 2006, a number of reports from patients have shown higher-than-normal rates of loosening and failure in the uncemented CR-Flex Porous Femoral component.

Has there been a Zimmer knee replacement recall?

To date, there has not been a Zimmer NexGen knee recall, but product liability attorneys and personal injury attorneys are evaluating Zimmer knee claims for patients who have experienced failure with the Zimmer NexGen CR-Flex Porous Femoral component.

However, there have been other Zimmer recalls. In December 2010, certain lots of the Zimmer NexGen LPS Flex Gender were recalled after patients complained about continuous pain after the normal healing timeframe. A number of these patients needed revision surgeries to repair the problem. A few months after the recall, Zimmer’s Durom Cup Replacement was back on the market.

In June 2008, Zimmer recalled its NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor, an instrument used during knee surgery. Zimmer issued the recall due to findings that the instrument could potentially break during surgery and could leave fragments of metal in the patient’s knee.

Yet another recall was issued in 2008 for a Zimmer surgical instrument used during knee arthroplasty surgeries: the Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument. This instrument was recalled due to the fact that it could fracture during surgery.

Why would the Zimmer NexGen CR-Flex knee be defective?

Data now indicates that the NexGen CR-Flex Porous Femoral component has been associated with unexplained pain after knee replacement, loosening of the implant and failure of the replacement knee leading to revision surgery. Some orthopedic surgeons believe the design is defective and unreasonably dangerous, and can potentially expose patients to an unnecessary risk of problems.

Researchers have found this Zimmer NexGen replacement knee systems “unacceptably high,” with many knee replacement patients experiencing loosening with the Zimmer NexGen CR-Flex Porous Femoral implant and requiring revision surgery within a few years.

Who is the Zimmer knee designed for?

It was designed and created to use in patients who have had a knee injury or failure such that they have lost the ability to adequately use their knee.  Because of its composite design, it was supposed to offer greater flexion than other knee implants, and it was thought that this design would suit younger and more active patients.

How do I know if I have the Zimmer NexGen CR-Flex Knee rather than another type of Zimmer knee replacement or even another brand?

Typically your orthopedic surgeon will discuss with you (before your surgery) what type of implant you will receive—there are a number of knee implant devices on the market.

To be certain of what kind of knee replacement device was implanted is to ask your surgeon for his operative report, which will detail the type and brand of knee replacement device which was installed. Or ask the hospital where you had the surgery. If you have a problem obtaining this report, an attorney can help.

What are common Zimmer Knee Problems?

Common complaints of defective Zimmer NexGen knees include: loosening of the knee implant, chronic pain, dislocation, grinding noises, inability to extend or flex the knee, and/or instability over the knee while standing or walking.

Is there a Zimmer NexGen lawsuit?

Although the FDA has not (yet) recalled the Zimmer NexGen CR-Flex knee implantable device, attorneys are reviewing and evaluating claims against the device. The FDA will continue to monitor and track adverse event reports for the NexGen CR-Flex Porous Femoral Component, and based on their data, a determination could be made at a later date as to what measures to take, including a possible recall. To be clear, this device has not been recalled at this time.

How do I know if I qualify for a Zimmer NexGen lawsuit?

If you have had Zimmer NexGen knee surgery and have since had your replacement knee revised or have had any issues such as loosening, pain, or difficulty walking, then you may have the grounds for a Zimmer NexGen CR-Flex Porous Component lawsuit.