Biocompatibility and characterization of a Kolsterised(®) medical grade cobalt-chromium-molybdenum alloy.

Abstract

High failure rates of cobalt-chromium-molybdenum (Co-Cr-Mo) metal-on-metal hip prosthesis were reported by various authors, probably due to the alloy's limited hardness and tribological properties. This thus caused the popularity of the alloy in metal-on-metal hip replacements to decrease due to its poor wear properties when compared with other systems such as ceramic-on-ceramic. S-phase surface engineering has become an industry standard when citing surface hardening of austenitic stainless steels. This hardening process allows the austenitic stainless steel to retain its corrosion resistance, while at the same time also improving its hardness and wear resistance. By coupling S-phase surface engineering, using the proprietary Kolsterising(®) treatment from Bodycote Hardiff GmbH, that is currently being used mainly on stainless steel, with Co-Cr-Mo alloys, an improvement in hardness and tribological characteristics is predicted. The objective of this paper is to analyze the biocompatibility of a Kolsterised(®) Co-Cr-Mo alloy, and to characterize the material surface in order to show the advantages gained by using the Kolsterised(®) material relative to the original untreated alloy, and other materials. This work has been performed on 3 fronts including; Material characterization, "In-vitro" corrosion testing, and Biological testing conforming to BS EN ISO 10993-18:2009 - Biological evaluation of medical devices. Using these techniques, the Kolsterised(®) cobalt-chromium-molybdenum alloys were found to have good biocompatibility and an augmented corrosion resistance when compared with the untreated alloy. The Kolsterised(®) samples also showed a 150% increase in surface hardness over the untreated material thus predicting better wear properties.