Zimmer Biomet Holdings Inc. announced on October 31 that it received FDA 510(k) clearance for the Persona revision knee system used in the revision knee replacement procedures. The purpose of a 510(k) submission is to signify that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976).
In the press release, Zimmer Biomet's vice president Todd Davis stated, "the clearance of the Persona revision knee system gives us the ability to provide surgeons with a full-service portfolio for the continuum of knee arthroplasty care, from diagnostic tools, cement spacer technologies to re-implantation solutions. The Persona revision knee system gives surgeons the flexibility to truly tailor an implant solution based on each patient’s unique anatomy for a natural fit and function.”
As of September 2018, there are 260 cases pending against Zimmer for inadequately warning patients and doctors about the adverse effects of the faulty knee implants manufactured by them. NexGen and Persona models of knee implants have been reported to fall out due to loosening of defective screws.
