Table 1.

General process for obtaining manufacture of a custom titanium sleeve to allow implantation with a revision style Biolox ceramic head (CeramTec, Plochingen, Germany).

Confirm that ceramic or Oxinium (Smith & Nephew, Inc., Memphis, TN) revision femoral head component is not currently available for fixed femoral stem. Request prosthesis trunnion specifications from femoral stem manufacturer. Confirm that the custom titanium sleeve will work with implanted prosthesis (fixed femoral stem). Obtain an assessment from a physician (orthopaedic surgeon) who is not biased concurring with plan to use the custom component. Obtain compassionate use device documentation through hospital or practice IRB if indicated. Submit device description including planned neck length and head size (Special products Implant Request Form). Review manufacturing plan. Forward purchase order to manufacturer for two devices (in case second urgent surgery is needed or the first implant is contaminated). Obtain patient consent after reviewing risks, benefits, goals, and alternatives. Sign informed risk document for surgery. Proceed with surgery when device is available but have appropriate backup plan for revision if device is not suitable.