Willmann G, Kälberer H, Pfaff H G
Cerasiv, Produktbereich Medizintechnik, Plochingen.
Biomed Tech (Berl). 1996 Oct;41(10):284-90.
In the field of hip arthroplasty, there is a clearly recognizable towards the use of modular acetabular cups involving metal-backed sockets into which cup inserts made of either polyethylene or alumina ceramic (Biolox forte) can be fitted. The design aspects for this concept have already been discussed in [17]. In the present paper, we discuss the question of component reliability and the criteria for testing acetabular cups with ceramic inserts. To date, neither standards nor government regulations for ceramic cups are available. In the absence of such regulations, those laid down bei the American Food and Drug Administration (FDA), together with our own longterm experience with femoral ceramic heads are used as a guide for the testing of ceramic cup inserts.