Zimmer NexGen Lawyer
The Zimmer NexGen artificial knee replacement in not attached by using cement or fixative. The new porous layer was intended to promote bone growth to keep the femur in position. The Zimmer NexGen was invented to reduce the risk of cement polluting nearby tissue, but created other problems, such as the loosening of the femoral device, damage to the nerves, infection, pain and leg length differences and instabilities.
Complications such as corrosion of the artificial components, blood clots and debris from wear of the knee have also been reported. The results of a study performed by Dr. Craig Della Valle and Dr. Richard Berger found that 9.3% of Zimmer NexGen CR-Flex artificial implants had either revision surgery or were scheduled to be revised. The report also found that thirty-six percent of 108 patients had a loosening of the porous femoral component.
If you have been injured by your Zimmer knee replacement, you are entitled to reimbursement for your harms and losses. Contact a defective Zimmer recall lawyer to discuss your case by calling (314) 409-7060, or 855-55-BAD-DRUG.
Zimmer NexGen Knee Implant Complications
Zimmer Holdings Inc., designing and marketing of orthopedic products, was founded in 1927 by Justin O. Zimmer. The firm is headquartered in Warsaw, Indiana and operates worldwide, with direct operations in more than twenty-five countries and sells products to approximately 100 countries. The company promoted the NexGen LPS Flex knee implants which are used in patients in knee replacement surgeries.
The product allows increased bending, compared to other knee replacements that can only bend 125 degrees. Knee bending occurs when the femur, (bone between the knee and pelvis), rolls on the tibia. The tibia is the bone situated between the knee and the ankle. The femur device was designed to provide extra roundness and to improve contact between the tibia and femur. The component was also designed with a deep shape in order for the knee-cap (patella) to move over the femur when the knee bends.
Research found that the artificial femur loosened within an average of thirty-two months. Out of 27 femur replacement components, revision surgery was required for 15 of the knees. It is also found that flexion occurred as a result from the femur device having loosened. Research found that the amount of weight a patient puts on the leg and bending activities add to the loosening of the component. It also came to light that some knees were unstable. Splintering of bones developed in the area of the implant and in some cases, malfunction of the muscles occurred.
Zimmer Recalls of NexGen Knee Implants
The U.S. Food and Drug Administration will allow products under the 510 program. If a medical device is similar to a product already on the market it can bypass the need for clinical trials. Zimmer argued that the new product was similar to the traditional NexGen product, which was approved by the Food and Drug Administration in 1994. In 2007 Zimmer also received approval for NexGen. Zimmer managed to sell untested products. Almost 160,000 patients received NexGen CR-Flex artificial knee implants.
Zimmer notified distributors and surgeons in September 2010 to remove NexGen devices, but no action was required. The Zimmer Company notified distributors and surgeons in December 2010 with a voluntary recall to urgently remove the knee implant devices and return the NexGen Complete Knee Solution LPS Flex Gender Femoral Components to the manufactures. The devices were specifically designed for women and had a different cam radius.
What is Wrong With Zimmer NexGen CR-Flex?
Dr. Richard A. Berger, a designer of artificial joints and surgical tools, implanted replacement knees for many years. Dr. Berger trained doctors across the country to use Zimmer products and Zimmer rewarded the master surgeon more than $8 million over the last ten years.
Dr. Berger notified Zimmer that a specific artificial knee product was failing too early and also published supporting facts that proved it. Zimmer’s chief scientist praised the master surgeon for his ability to innovate surgical techniques, which was profiled on ABC’s World News. After Dr. Berger published a study on the defect on the Zimmer knee replacement, Zimmer told the doctor that the problem was not with the artificial knee, but with the doctor’s technique.
Dr. Berger says that the device was supposed to last about fifteen years. In 2005, he gave the devices to about 125 patients. In 2006 patients reported pain, caused by the loose joints that did not fuse completely. In 2007 Dr. Berger learned that several other surgeons also experienced problems with the Zimmer knee at issue. Dr. Berger said he has lost confidence in Zimmer.
Faulty Zimmer Knee Replacement System
Zimmer recalled all of the NexGen MIS Tibia Components. The results of studies were published in prominent publications, such as the British Journal of Bone and Joint Surgery. Studies found that twenty percent of Zimmer NexGen Legacy Posterior Stabilized Stabilized-Flex Fixed total knee replacements become loose. All of these cases required revision surgery.
There are several Zimmer NexGen knee replacement problems that can occur. It remains important that you consult with your doctor, even if you have not yet experienced a problem. Common problems that usually occur include osteoarthritis, instability, pain and stiffness.
Claims and Lawsuits Against Zimmer
Plaintiff Ronnie Clark filed a lawsuit against Zimmer in 2011 and claimed that Zimmer wrongly and misleadingly sought to create the image and impression that using the Zimmer NexGen knee was risk-free. The plaintiff had two revision surgeries.
In December 2011, John Hall claimed his Zimmer NexGen artificial knee caused consistent pain and he had to undergo revision surgery in 2008. The plaintiff claimed that the company should have known that the implant created a high risk of unreasonable dangerous side effects.
Catherine Pollow-Daniel claimed in her 2011 lawsuit that Zimmer was aware of the fact that the product had risks involved, such as injury and significant pain.
At first, there were 28 lawsuits on file when the Zimmer multidistrict litigation was established. There are now more than 700 cases transferred to the multidistrict litigation, in the U.S. District Court for the Northern District of Illinois. The Zimmer products that are included in the federal MDL are All NexGen MIS Total Knee Procedure Stemmed Tibial Components, NexGen Complete Knee Solution CR-Flex, NexGen Complete Knee Solution Gender Solutions Female LPS-Flex, NexGen Complete Knee Solution Cruciate Retaining-Flex Femoral Components and NexGen Complete Solution Legacy Posterior Stabilized-Flex Femoral Components.
Zimmer Knee Recall Injury Attorney
If you have been injured by a Zimmer product or other metal hip or metal knee implant, contact a defective medical implant lawyer to discuss your right of reimbursement for your harms and losses. Any company who unnecessarily endangers the public in the name of profits must pay for the harm they cause. Contact a medical device lawyer for more information by calling (314) 409-7060 or completing our online contact form for an immediate call back.