Everyone who has responsibilities in connection with surgical implants should be aware of his potential contribution to failures as well as to successes. The designer should test his device in all appropriate ways before suggesting its use. The fabricator should use the best materials available and the proper manufacturing techniques; he should make careful tests at each stage and keep adequate records. The distributor should be responsible for adequate labeling and packaging; in case of failure the origin of the implant should be traced. Thus, any systematic lapse in proper technique can be corrected. Operating-room personnel should be instructed in the proper storage, identification, and handling of orthopaedic implants. Finally, the surgeon should use a high level of judgment, conservatism, and skill in applying these mechanical devices.
Perhaps the major reason for failure of implants is faulty application of the device. From the standpoint of engineering, every device has points of weakness at which it will fail when the margin of safety is exceeded. It is the designer's responsibility to provide an adequate minimum margin, and it is the surgeon's not to cxceed that margin. Mere demonstration of an area of relative weakness in a device is not sufficient evidence that this weakness was the cause of failure. The real reason for failure in a device may be that more was expected of it than it was designed to do. Cooperative investigation of all metal failures by surgeon, metallurgist, and pathologist will explain a large number of failures. Moreover, such studies will provide invaluable basic information for the prevention of errors in all phases of surgical implantation from design to ultimate use of the device.
Copyright 1964 by The Journal of Bone and Joint Surgery, Incorporated