Zimmer Knee Replacements
Zimmer Manufacturing Company began operations in 1927selling a line of aluminum splints. Today the company has a catalog of many thousands of orthopaedic implant systems, reconstructive spinal and trauma devices, dental implants and other artificial joint products. Zimmer is a very large company with net sales that are in excess of $4 billion. $2.4 billion of those sales are made in the United States. Zimmer’s knee implants make up a bulk of its worldwide sales at approximately $1.8 billion. Zimmer remains the largest maker of knee replacement implants in the world with a market share of about 26%.
One of the more recent innovations by Zimmer in its knee implants division was the development of the NexGen Flex knee implants which were designed to replicate the natural motion and function of a knee and provide a patient with a greater range of motion. The Zimmer devices like NexGen Lateral Posterior Stabilization (LPS) – Flex, NexGen Cruciate Retaining (CR) – Flex and NexGen Minimally Invasive Solutions (MIS), Tibial Component have given way to many lawsuits filed by patients who required revision surgeries because of complications of pain in the joint and loosening and premature failure of the Zimmer knee implant.
In addition, Zimmer makes a wide variety of knee replacement products. Some of the products are cemented, others are non-cemented components. The company also have developed and sold total knee replacements, implants without compartments, femoral implants, tibial implants and patellar implants. In fact, Zimmer makes its implants that are purposed and modeled for male and/or female patients. So they are gender specific.
The Zimmer NexGen Flex Knee System is its flagship and most successfully marketed and sold knee implant product. The implant is designed to allow a patient bending and extension or straightening of the leg. A person with a healthy knee can bend up to 160 degrees flexion. The industry standard for knee implants and Zimmer’s NexGen Flex Knee System offers 120 degrees of flexion. The U.S. Food and Drug Administration (FDA) approved the NexGen Flex devices in 1999. The NexGen LPS-Flex Fixed-Bearing Knee was marketed to provide flexion of 155 degrees instead of the standard 120 degrees. This new knee device was intended to be used by younger, more active patients who could best utilize this knee implant. In addition, it was heavily marketed to those in the areas of the world whose cultural background and religious beliefs required kneeling or bending in prayer. More than 150,000 NexGen Flex Knees have been sold and implanted.
Although successful in some of its products, the knee replacements made and manufactured by Zimmer have created many patient problems. It has been claimed that Zimmer, who was not required to test these devices before release, knew that there were problems with them. There were no clinical trials. Patients who received the NexGen Flex implants were given untested devices. The FDA has since received hundreds of reports of serious problems related to the NexGen Flex devices. Complications include poor range of motion, loosening of the knee components and device failure. There has been a high number of revision surgeries reported.
In fact, in March 2010, Dr. Richard Berger and Dr. Craig Della Valle, both associated with Rush University Medical Center in Chicago, concluded that a new study of the Zimmer CR-Flex component concluded that it should be removed from the marketplace. The reviewing doctor stated that it should “not be used by any patient” because of its high failure rate and bad design. The Journal of Bone and Joint Surgery has reported that generally the life span of a knee implant is 15-20 years as of 2007. But the Journal showed that 38% of the LPS Flex knees loosened after just two years of use. 56% of LPS Flex knee implant patients were obliged to undergo revision surgery because of pain. One in five patients implanted with Zimmer’s NexGen Flex knees have found to be reporting extremely limited flexion in activities like squatting, kneeling and sitting on heels- activities that Zimmer claimed would be more than possible with this implant.
Other problems with Zimmer’s NexGen’s tibial component have been found to have early failures. Zimmer has not recalled devices despite the multiple reports of complications and failures. A Class II Recall was declared in September 2010 by the FDA. At the time of the recall, more than 68,000 MIS tibial components had already been implanted in patients. The FDA issued another Class II Recall for another one of Zimmer’s knee implant components, the Natural-Knee II Durasul All-Poly Patella. There are nearly 110,000 of these components already implanted at the time of the recall.
There have been hundreds of lawsuits filed against Zimmer because of its NexGen Flex Knee products that have failed and caused injuries to patients. These cases have been filed all around the country but have been consolidated in the United States District Court for the Northern District of Illinois in Chicago. The Multi-District Litigation (MDL) includes the following Zimmer NexGen Flex Knee devices:
- NexGen Complete Knee Solution Legacy Posterior Stabilized-Flex Femoral Components (LPS-Flex)
- NexGen Complete Knee Solution Cruciate Retaining-Flex Femoral Components (CR-Flex)
- NexGen Complete Knee Solution Gender Solutions Female LPS-Flex (GSF-LPS-Flex)
- NexGen Complete Knee Solution CR-Flex Gender Solutions Female CR-Flex (GSF-Flex)
- All NexGen MIS Total Knee Procedure Stemmed Tibial Components
The many personal injury lawsuits that have been filed against Zimmer claim that the NexGen Flex Knee design was faulty and that the devices fail at an alarmingly high rate that is unacceptable for use. According to the Master Complaint filed in this Multi-District Litigation case, plaintiffs have alleged that NexGen Flex Knees “failed to provide additional or meaningful flexion beyond 120 degrees.”
If matters couldn’t be worse for Zimmer given all of these product defect lawsuits, there has also been a $169.5 million settlement that Zimmer paid for civil charges against the company brought on by the U.S. Securities and Exchange Commission (SEC). The SEC claimed that Zimmer had “bribed” doctors to use its products by offering them paid consulting agreements and other financial benefits. That case is settled, although the other lawsuits for the injuries remain pending in the district court in Chicago.
If you or someone you know has been injured as a result of a medical device defect such as a Zimmer NexGen Flex Knee products, please call us for an immediate free consultation.
Robert Kreisman of Kreisman Law Offices has been handling medical device defect injury cases for more than 40 years. Kreisman Law Offices has prevailed in trials and settlements in Chicago, Illinois and surrounding communities and has successfully resolved cases for those injured because of medical device defects.
With our 40 years of experience in trying and settling medical device defect cases, Kreisman Law Offices provides the best possible services to our clients and have achieved unsurpassed results. Our service is unmatched. Please call us 24 hours a day at 312.346.0045 or toll free 800.583.8002 for a free and immediate consultation, or complete a contact form online. There is no charge for a consultation that will include an evaluation of your case, assessment of damages such as lost income, lost wages, medical and hospital bills, past and future pain and suffering, loss of normal life and wrongful death.