Ceramic femoral head retrieval data

Abstract

In the 1970s it was first realized that the properties of alumina ceramics could be exploited to provide better implants for orthopaedic applications. Applications depend on the fact that ceramics provided wear characteristics suitable for bearing surfaces in total hip replacement. Resultant orthopaedic use had more than 20 years' clinical success. To date more than 2.5 million alumina femoral heads have been implanted. Published reports of fracture rates of the alumina heads range between 0% for ceramics manufactured after 1990 and 13.4% for ceramics manufactured before 1990. These high fracture rates were caused by materials manufactured by companies that are not on the market today. These old aluminas had a low density, had a very coarse microstructure, and were not in compliance with specifications that are valid today. Materials scientists have substantially improved the mechanical strength of alumina. There are three generations of medical grade aluminas. The latest generation is an alumina that is hot isostatic pressed, laser marked, and proof tested. This material has been on the market since 1994. The fracture rates of the most commonly used ceramics have been analyzed by various groups, and are based on .5 million femoral heads to 1.5 million femoral heads. The fracture rate of ceramic Biolox femoral heads are 0.026 % for first generation alumina, 0.014% for second generation alumina, and 0.004% for femoral heads manufactured after 1994. Analyzing the clinical experience of more than 20 years, it can be concluded that all the improvements have produced reliable ceramic femoral heads.