Zimmer, now known as Zimmer Biomet, based in Indiana, has been issued a Class 1 recall for the M/L Taper with Kinectiv Technology hip implant. The U.S. Food and Drug Administration (FDA) has recalled the Zimmer hip implant due to a manufacturing issue. This device is part of a modular system of femoral necks and stems able to be custom-fitted to a patient’s anatomy. “The company found a process monitoring failure that led to higher than expected amounts of manufacturing residue left on the devices,” stated the FDA’s website.
A Class 1 recall is a situation in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death. The reason for the Zimmer hip implant recall is a risk of metallosis, a condition often associated with metal-on-metal hip implants. The symptoms may include skin rash, heart disease, hearing or visual impairment, kidney failure if left untreated, depression, thyroid dysfunction leading to possible weight gain, temperature sensitivity, fatigue, or neck discomfort.
“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,” according to the FDA.
Shavings from the metal can fly off and after the procedure is over, the product may still be coated with an oil-based residue. Other contaminants are microbiological and particulate debris, that, if not removed, can be problematic for the patient, according to Qmed.
DePuy Synthes, OMNI, Smith & Nephew, Stryker, and Wright Medical Technology, all facing lawsuits or recalls for defective devices, are now joined by Zimmer Biomet.