A pictographic atlas for classifying damage modes on polyethylene bearings

Abstract

Evaluation of medical devices retrieved after in vivo service provides unique evidence related to the physiological environment in which the biomaterials performed. This study implements a training procedure for evaluating polyethylene bearings of joint prostheses obtained after pre-clinical tests or explanted after in vivo function. A total of 161 damage regions on 45 bearings were evaluated by four observers. An illustrated Damage Mode Atlas was developed as a reference guide, inclusive of both photographs and concise written descriptions of 16 specific damage modes that are typical for polyethylene bearings. Utilizing the Damage Mode Atlas to train new researchers improved the damage pattern analysis, including more accurate identification of damage modes and improved inter-rater reliability. This Damage Mode Atlas is a useful supplementary tool for conducting Stage II non-destructive analysis of explanted polyethylene bearings used for joint replacement, in accordance with international guidelines for evaluating explanted medical devices.