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In Brief: Hip joint resterilization

This article was originally published in The Gray Sheet

Executive Summary

Hip joint resterilization: FDA "Dear Colleague" letter warns against steam resterilization of total hip joint prostheses with zirconia ceramic heads. Manufacturers of these devices should note that "surface roughening of zirconia ceramic femoral head components" has been associated with steam resterilization, FDA says. "As a consequence of this roughening, increased wear on the ultra-high molecular weight polyethylene acetabular component may occur, which can cause premature failure and require early revision." To avoid the phase transformation in the crystal structure of the zirconia material caused by steam and elevated temperatures, FDA recommends that manufacturers sterilize zirconia hip prostheses using ethylene oxide...
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