DeviceMatters

Medical Device Safety Reports

DeviceMatters helps medical device professionals gain access to valuable regulatory and safety insights and analytics. These insights help identify the most effective ways to improve medical device quality and safety, identify and assess risks, and differentiate products in the marketplace. DeviceMatters reports also provide an early warning system for OEMs, investors, payor/providers about potential quality problems that are leading to patient adverse events and pose a safety and a recall risk. For example, DeviceMatters data identified the product code KWA, Metal Uncemented Acetabular Component Semi-Constrained Hip Prostheses, as the third greatest driver of adverse events for J&J in 2008. It took both the FDA and J&J several years, however, to finally recall the DePuy ASR metal-on-metal hip implants in August 2010.