Zimmer Knee Replacement
About Class Action Litigation and Multi-District Litigation
When corporations or organizations, through their carelessness, harm large groups of individuals, class actions arise. A class action is brought when multiple people suffering the same type of injury sue as a group. The purpose is to eliminate a wrong that has affected a large amount of people by providing a judicial remedy and financial compensation to all members of the class. At Garson Johnson LLC, in Cleveland, Ohio, we have handled multiple class actions and know what needs to be done to secure justice for you.
Zimmer NexGen Knee Replacement System Recall
Since 2003 an estimated 150,000 NexGen knee replacements have been sold. The NexGen devices were specifically designed to increase the patient's knee flexion from the industry standard 120 degrees of motion to 155 degrees of motion. The Zimmer NexGen LPS-Flex knee replacement device was the first device in the Zimmer NexGen line and was marketed to provide added flexion and stability in the knee joint. The device offers a posterior stabilization module while the surgical procedure requires the removal of the anterior and posterior cruciate ligaments which are the natural stabilization mechanisms in the knee joint. The FDA approved the NexGen LPS in 1999 through the 510(k) premarket notification process. This premarket notification process allows medical device manufacturers to issue devices without testing them so long as similar products are already on the market. Typically medical device manufacturers design knee implants to last between 10- 15 years. While in effect, as published in a report in the Journal of Bone and Joint Surgery, the LPS-Flex replacement showed as high as 37% of the replacements to become loose within 2 – 3 years.
Failure of Zimmer NexGen CR-Flex and LPS-Flex knee replacements
The LPS-Flex shares common components with the Zimmer NexGen CR-Flex knee replacement. The CR-Flex attaches to the thigh bone without cement, the adhesive which is most commonly used in the knee replacement industry. Moreover, the CR-Flex was specifically designed for individuals who did not require the added flexion in the knee joint found in the LPS-Flex. Unfortunately, as a result of complications associated with the uncemented implants it is estimated that nearly 9% of the NexGen CR-Flex knee replacements have required a revisionary surgery after implantation. The premature failure of Zimmer NexGen CR-Flex and LPS-Flex knee replacements have been associated with symptoms including significant increased joint pain due to loosening of the device where it attaches to the thigh bone. Dr. Richard Berger and Dr. Craig Della Valle from the Rush University Medical Center determined in their study on the CR- Flex in March 2010 that the CR-Flex should be recalled from the market due to the probability of premature failure and the inadequate design. Yet, despite the complications with these devices Zimmer has yet to recall either the CR-Flex, or the LPS-Flex devices.
However, as of March 12, 2015 the Zimmer Persona porous coated uncemented Trabecular Metal Tibial Plate was classified by the FDA as a Class II recall. Following suit, Zimmer voluntarily recalled these devices. Upon issuance of the recall for the devices Zimmer dealt out a notice of quarantine to hospitals, doctors, and distributors alike. The recall has affected an array of patients including those with the models C – J for both the left and right knees. At the time of the recall an estimated 68,000 tibial components had been implanted.
Zimmer NexGen Lawsuits
Plaintiffs have alleged Zimmer's NexGen Flex knee design is faulty apparent in the unacceptably high rate of failure and that the knees fail to provide additional flexion beyond 120 degrees of motion. Zimmer has already paid nearly $170 million in settlements filed by the Securities and Exchange Commission due to the defective knee replacements. Zimmer still asserts the blame is to be allocated to the orthopedic surgeons rather than their faulty Persona Flex Knee replacement design.
If you or a loved one have experienced unexplained knee pain or a looseness in the replacement joint or difficulty walking or exercising following a Zimmer knee replacement surgery please fill out the contact sheet to have your case evaluated for free today.