Reporting adverse incidents: joint replacement implants

Manufacturers of joint replacement implants are required to report adverse incidents related to their products. This guidance outlines the specific procedures for doing so, in conjunction with MEDDEV 2.12/1 guidelines on a medical devices vigilance system. The focus is on incident reporting obligations for manufacturers of these implants. Adverse events such as device failure, infection, or other complications must be documented and reported to regulatory authorities as per established protocols.