The FDA's Sentinel Initative, launched August 11th for Medical Device Manufacturers, aims to track Medical Device Performance. According to HealthPointCapital :

The Sentinel program, launched in May, strives to be "a national, integrated, electronic system for monitoring medical product safety." The FDA is now in the process of initiating the orthopedic device arm of the program, which seeks to evaluate the performance of total hip, total knee, hip resurfacing, intervertebral disc implants and ankle devices of through the collection of registry data. This data collection process, per the FDA, should require minimal data transfer and protect patient privacy.

SigmaQuest's SigmaSure™ solution helps Medical Device manufacturers comply with the FDA's Sentinel Program.