Fatigue performance of ultra-high-molecular-weight polyethylene: effect of gamma radiation sterilization.

Ultra-high-molecular-weight polyethylene (UHMWPE) failure presents a significant materials concern in the orthopaedic community. Clinical failure following joint arthroplasty can result from the biological response to wear debris as well as structural failure owing to UHMWPE fatigue. In this study, cantilever rotating beam fatigue testing was conducted on GUR 415 UHMWPE in both the unsterilized and gamma radiation sterilized conditions. Calculations of flexural fatigue stresses were based on extreme fibre stresses and assumed negligible plastic deformation. Both material conditions exhibited similar fatigue strengths at 250,000 cycles (approximately 41 MPa) and at one million cycles (approximately 36 MPa), but a large difference developed after two million cycles. At ten million cycles, the unsterilized condition exhibited a fatigue strength of approximately 31 MPa, while the gamma-sterilized condition exhibited a reduced fatigue strength of approximately 18 MPa, an approximate decrease of 42%. High-cycle fatigue testing was necessary to fully characterize this behaviour owing to the pronounced difference in fatigue behaviour beyond two million cycles. These results suggest that gamma radiation sterilization of UHMWPE medical implants reduces their resistance to cyclic loading and, subsequently, may contribute to the associated fatigue-related failures which have been reported clinically.