SummaryOrthopedic appliances of type 316 (SMO) stainless steel were examined in detail after being removed from human subjects. Techniques included conventional microscopy with various lighting methods, together with electron microscope fractography. Corrosion, fatigue failure, and manufacturing defects were identified and statistically tabulated. of all mult icomponent devices and the overall incidence of fracture failure was 9%. These results indicate an urgent ueed for st,ronger, more corrosion-resistant implant alloys.
Corrosion damage occurred on 91Metals and alloys are presently used in a number of implantable bioassists, such as pacemakers and heart valves. The most widespread use is, of course, in the multitude of orthopedic devices used as fixtures and prostheses. With these devices, as with any other engineering component, the examination of a part which has seen service can provide valuable design information. Too frequently the necessary information is riot obtained because of a lack of proper technical background or the destruction or omission of unrecognized evidence.The problem of materials in relation to surgical or orthopedic implants has been the subject of previous investigations conducted by Scales et at.',2 and Cohen. Scales examined devices of various compositions extracted a t random for evidence of corrosion, while Cohen examined devices removed for cause. I t was discovered in both these studies that corrosion was occurring in a considerable number of cases. This investigation enlarges the available information on 316 SR'IO and presetits details previously not obtained.
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