Device Dossier
DePuy CMW 3 Gentamicin Bone Cement - Orthopaedic cement, medicated
Device Dossier for DePuy CMW 3 Gentamicin Bone Cement - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor DePuy Synthes).…
- GMDN category: Orthopaedic cement, medicated
Intended purpose
Indicated for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin sensitive organisms is a potential risk.
Functional description
Self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The device relies on close mechanical interlock between irregular bone surface and the prosthesis. It is supplied as a two-component system, consisting of separate, sterile liquid and powder components, which are mixed together at the point of use to produce the cement.