Last year, Zimmer Inc., one of the largest orthopedic device manufacturers in the world, quietly recalled a number of tibial components used in the Zimmer NexGen Complete Knee Solution MIS procedure. Though the Zimmer NexGen MIS tibial component recall was issued in September 2010, Zimmer did not issue any type of public announcement. It wasn’t until March 2011 that the <"http://www.yourlawyer.com/topics/overview/Zimmer-NexGen-MIS-Tibial-Component-Complete-Knee-Recall-Lawsuit">Zimmer NexGen MIS tibial component recall was added to the U.S. Food & Drug Administrationâ€™s (FDA) website.
The Zimmer NexGen MIS tibial component recall involved NexGen TM Tibial Trays, NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
About 68,384 knee components were recalled, which were distributed in 13 states across the U.S., including Arizona, Illinois, Indiana, Kentucky, Missouri, Nebraska, New Mexico, New York, Ohio, Texas, Virginia, Washington, and Wisconsin. The components were also sold in Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Taiwan and Thailand. It is unclear just how many of those components were implanted in patients at the time of the recall.
Problems with the components appeared to be preventing them from fusing to bone. According to the FDA, there have been 114 reports of complications associated with the recalled Zimmer NexGen MIS tibial components. The reports involve loosening of the knee replacement, and in all 114 reports, patients required revision surgery.
The September recall came after Zimmer issued an “Urgent Device Correctionâ€ letter about complications involving the NexGen MIS Tibial knee components, and instructed medical professionals to use a modified surgical technique when implanting the affected device. The company issued the modified surgical instructions in response to dozens of reports of component loosening and device failure. Zimmer also warned surgeons to fully cement and pressurize the anterior and posterior surfaces of the tibial component and recommended the use of a drop down stem extension.