A Class I recall has been issued for certain Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks, the U.S. Food and Drug Administration (FDA) announced recently. The agency said the recall was issued because the parts may have “unexpected amounts of manufacturing residues”. The Class I designation is reserved for recalled devices that present a reasonable risk of serious injury or death.
According to the FDA notification, the recalled devices contain higher than expected amounts of residue due to a a process monitoring failure. “These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant.”
Surgeons use the recalled devices to help fit a hip implant to each individual patient. The affected components were manufactured and distributed between March 31 and April 20, 2015. A recall notification was issued on May 18.
Qmed reports that Zimmer may not be the only manufacturer facing residue issues. John S. Bolinder, vice president of marketing and communications at Nelson Laboratories notes the risks of the machining and milling process used to manufacture orthopedic implants. During the machining and milling, metal shavings can fly off. The device may also be contaminated with aqueous or oil-based residue used as cutting fluids. “For instance, I read an article about eight years ago, about a patient with a metal knee implant who died from a stroke two weeks later,” said Bolinder, according to Qmed. “Why? Several complications including infection and particulates coming off the device, entering the cardiovascular system and ultimately causing his heart to stop.”