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…

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.

TGA Public Summary