Last September, Zimmer Inc. issued medical device recalls for NexGen Complete Knee Solution LPS femoral components and NexGen Complete Knee Solution MIS tibial components. While doctors were informed of these Zimmer knee replacement component recalls, it does not appear that either the company or the U.S. Food & Drug Administration (FDA) made any public announcement of these actions.
The Zimmer NexGen LPS component recall involved 158 flex gender femoral components (recall #Z-0534-2011) and 192 femoral components (recall #Z-0528-2011) of various sizes. The devices were sold in the U.S., Germany, Spain, France, UK, Italy, Sweden, South Africa, Czech Republic, Bulgaria, Poland, Romania, and Austria. These recalls were issued because some of the devices were found to have nonconforming and inconsistent geometry.
According to the recall notices for these actions, surgeons were informed of the issue but there was no action to be taken by surgeons. Zimmer sent “Urgent Device Correction and Removal” notices to distributors and sales staff, Risk Managers, and implanting surgeons dated 9/15/2010. Sales staff and risk managers were instructed to return any devices on hand. Neither of these recalls was posted on the FDA’s database until December 2010.
Just two days before Zimmer issued the NexGen LPS femoral component recall, the company recalled a number of tibial components used in the Zimmer NexGen Complete Knee Solution MIS procedure. While that recall was issued on September 13, 2010, information about the recall wasn’t updated on the FDA database until last month.
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.
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. Problems with the components appeared to be preventing them from fusing to bone. In April 2010, Zimmer sent an “Urgent Device Correction” letter to surgeons instructing them to use a modified surgical technique when implanting the affected components.
More than 68,000 of these Zimmer knee replacement components were involved in this recall. The components 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.