Zimmer is one of the largest manufacturers of knee replacement implants in the world, with numerous options available to address knee replacement surgery. While the organization has provided knee replacements for some years, they have recently begun dealing with issues with some of their replacement models.
Recall and Warning Issues
While Zimmer’s NexGen products consist of several different options, some have certainly come under fire as of late due to research and complaints filed with the FDA. The LPS-Flex Nexgen from Zimmer was the subject of a 2007 study that showed that out of 47 patients, with a combination of both single and double knee replacements, 15 knees required revision after only 23 months, and by 32 months, 27 patients had suffered from the femoral portion of the device loosening.
One of Zimmer’s components, the NexGen MIS Tibial components, were the subject of an FDA Class 2 recall in 2010. A Class 2 recall is issued in situations where exposure to or use of a product could result in temporary adverse health consequences that require surgery to reverse them, or when the risk of adverse reactions deemed as serious are remote. However, 114 complaints were filed with the FDA due to the components loosening and requiring revision surgical procedures. In addition to those reported to the FDA, research on patients receiving the device showed that the loosening occurred in 130 of the components, within an average period of only 17 months.
Later in 2010, Zimmer issued an Urgent Device Correction letter after clinical data research showed that there was an increased chance of loosening occurring if a stem extension or complete cementing was not used when inserting the device.
2012 saw another warning issued by the ECRI Institute concerning NexGen femur and tibia components that were failing. The High Priority Medical Device Alert, which was issued to thousands of worldwide hospitals, warned that the failures were the result of surgeons using articulating plates that were plastic and incompatible with the bone mounting device ends.
The Mayo Clinic also published research in January that another NexGen component, the LPS-3 tibial tray, was also showing signs of an increased failure rate. The cause of this failure was due to the cement used to secure the device becoming “debonded” from the metal portion of the components. Though there was not an exceedingly high number of these issues reported, the Clinic reported their findings due to the “surprising” cause of the failure.
Zimmer NexGen Failure
Patients requiring revision due to NexGen failures typically had to do so based on some problems, including:
- Decreased range of motion
- Severe pain in the knee
- Failure of the device
- Loosening of the components
In many cases, the Zimmer NexGen LPS-Flex knees required revision. Even though replacement knees have an average lifespan of 15 to 20 years, the Journal of Bone and Joint Surgery published a report indicating that the loosening of these knees was occurring within two years. Additionally, even though Zimmer marketed these knee replacements as providing an increased range of motion, it was reported that 1 in 5 of the patients receiving the implants had extremely limited high-flexion abilities when it came to kneeling, sitting and squatting.
While Zimmer NexGen knee replacements have proven effective for the most part, the devices have also shown failure rates that are troublesome, and can result in the need for additional surgery due to pain or failure. If you were injured or required additional surgery after having a NexGen knee replacement, compensation might be available to you. Contact an attorney for more information.