The International Consortium of Orthopaedic Registries: Overview and Summary

itors both mandatory and voluntary post-market reporting to identify adverse events and problems associated with medical devices. Although the manufacturers of medical devices are re-quired to report deaths, injuries, and malfunctions directly to the FDA, the device users are required to report these events to the manufacturer and are required to report only deaths to the FDA. Voluntary reporting systems such as the MedWatch pro-gram, the MAUDE (Manufacturer and User Facility Device Experience) database1, and the MedSun (Medical Product Safety Network) enhanced surveillance network2,3 provide nationwide medical device surveillance in the U.S. However, these reporting systems have important weaknesses, such as incomplete, inac-curate, or nonvalidated data, reporting biases related to event severity, concerns that reporting may result in adverse publicity or litigation, and general underreporting of events. Most im