Device Dossier

Refobacin® Bone Cement R - Orthopaedic cement, medicated

Device Dossier for Refobacin® Bone Cement R - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor Zimmer Biomet). ARTG…

Intended purpose

Refobacin® Bone Cement R is indicated to be used for stable anchoring of suitable joint prostheses to the bone, in hip and knee primary arthroplasty operations, also in case an infection with gentamicin-sensitive strains is a potential risk.

Functional description

Refobacin® Bone Cement R is a fast-setting acrylic polymer, containing gentamicin, for use in arthroplasty operations. 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