Medical device maker Zimmer, Inc. has announced the recall of the Persona Trabecular Metal Tibial knee replacement device. The recall was initiated because of increased reports of device loosening and radiolucent lines.
According to the recall announcement on the Food and Drug Administration (FDA) web site, the recall covers the Persona Trabecular Metal Tibial Plate/Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, all lots land sizes, left and right knee models. Radiolucent lines on scans, which show the gap between the cement and the device component, can be associated with early failure of the device. Some recipients have needed revision surgery to replace the defective knee component.
More than 11,500 devices are being recalled, in a Class II recall. In a Class II recall, “use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the FDA.
In the U.S., the devices were distributed in Alaska, Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin, and internationally in Canada, Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, Luxembourg, Netherlands, South Africa, Sweden, Switzerland, and United Arab Emirates. The recall announcement includes a list of hospitals and facilities that purchased the device.
Zimmer, which is based in Warsaw, Indiana, said it is removing all lots of the knee devices from distribution and sent Urgent Medical Device Recall notices to distributors, hospitals, and surgeons last month. Any facility with the affected devices on hand should remove them from inventory and return them to Zimmer. For questions about the recall, customers should contact Zimmer at 1-877-946-2761, from 8:00 a.m. to 5:00 p.m. EST.