ABSTRACT
With the exception of a very small number of studies, orthopaedic devices that “fail” in service are still not routinely or systematically collected and studied. Studies of those implants that are collected tend to concentrate on the physical ndings obtained from the device itself, neglecting the patient and events of treatment. Clinical reviews and case reports of implant malfunction tend to focus on the patient, often to a near total exclusion of an engineering description of the device. Finally, both types of study concentrate on frank failures, with an absence of comparative data from successful or partially successful performance of similar or identical devices. Thus, much of what we think we know about orthopaedic device performance is drawn from a very small, nonrandom sample of the actual clinical experience. This is an error, in the same way that studies of criminology based solely on prison populations are.
