Risk analysis for a radio-carpal joint replacement.

Risk analysis is required by the medical device directives to provide evidence that manufacturers have eliminated or reduced risks as far as possible so that a medical device does not compromise the safety of patients or health workers. This paper presents a risk analysis for the Swanson wrist implant, which is made from an implantable-grade silicone elastomer and used to replace the radiocarpal joint in the rheumatoid wrist. The main hazards identified were that the implant fractures and that silicone synovitis occurs in patients. The results of this risk analysis will be used to aid the design of a new wrist implant.