On March 12, 2015, the FDA announced a recall of Zimmer Persona Trabecular Metal Tibial Plate knee implant products. The recall is for all lots and sizes, amounting to more than 11,000 devices.
Though the recalled devices were initially portrayed as safe by the manufacturer, Zimmer, Inc., they have been shown to loosen, causing pain, swelling, and additional damage to bones and tissue. The loosening may require replacement of the device, forcing the user to re-experience the pain, suffering, and hardship of the initial replacement.
“Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution,” the FDA stated.
The recalled knees were implanted in medical facilities across the country, including Alaska, Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.
Radiolucent lines are the gaps between the bone and the implant components or between two components of the implant. The term radiolucent means that the gap is visible on radiological studies, such as x-rays. Fluid and tissue debris can fall into the gaps, causing pain.
Per the FDA Announcement, “all affected product are to be located and quarantined immediately.” Quarantining the uninstalled implants will prevent additional patients from potential pain and revision surgeries, but those already implanted with the Persona knees still face current and future complications.
Our law firm is helping patients with personal injury claims against Zimmer, Inc. Brendan Flaherty is our lead lawyer for these cases. He was on the team that won $45 million for clients injured by another medical product made by another company. You can click here now to request a free consultation with Brendan.