Device Dossier
Refobacin Plus Bone Cement - Orthopaedic cement, medicated
Device Dossier for Refobacin Plus Bone Cement - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor Zimmer Biomet). ARTG…
- GMDN category: Orthopaedic cement, medicated
Intended purpose
Refobacin Plus Bone Cement is used for stable anchoring of suitable joint prostheses in primary operations, with added protection against infection also in revision operations resulting from aseptic loosening of the prosthesis and infection of the prosthesis by gentamicin sensitive strains.
Functional description
Refobacin Plus Bone Cement is a fast setting polymer, containing gentamicin, for use in bone surgery. The gentamicin content protects against infections caused by bacterial invasion of the implant and the surrounding tissue by gentamicin-sensitive strains. Mixing of the two component system, consisting of a powder and a liquid, initially produces a paste, which is used to anchor the prosthesis to the bone.