A 2010 study of 108 patients with Zimmer NexGen CR-Flex knee replacements found that the device had a failure rate of 9.3%, while 36% of patients fitted with the Zimmer knee replacement experienced significant loosening of the device. According to the data collected by the knee specialists who conducted the study, the complications that occurred in Zimmer knee replacements were not related to the surgeon, surgical procedure, or type of patient.
In September 2010, Zimmer issued a recall for several of the components used in their knee replacement systems due to design or manufacturing issues.
Since 2003, Zimmer Holdings has sold over 150,000 NexGen knee replacements. Some recipients of these devices developed Zimmer knee problems, including knee stiffness, swelling, constant knee pain, infection, and difficulty walking or standing. The high failure rate of these devices could be an indicator of future hazards for those who are not currently experiencing symptoms of knee replacement loosening or failure. If these devices, which should last up to 15 years, are failing only a few years following surgery, it is not unreasonable to think that other patients with the cementless Zimmer NexGen CR-Flex knee replacement may experience early Zimmer knee replacement failure.
In September 2010, Zimmer issued a recall for several of the components used in their knee replacement systems due to design or manufacturing issues, though no recall has been issued for the knee replacement itself despite an increasing number of surgeons who have called for the device to be taken off the market, citing safety and design issues.