Device Dossier
Hi-Fatigue G Bone Cement - Orthopaedic cement, medicated
Device Dossier for Hi-Fatigue G Bone Cement - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor Zimmer Biomet). ARTG…
- GMDN category: Orthopaedic cement, medicated
Intended purpose
Hi-Fatigue G Bone Cement is a gentamicin containing poly(methyl methacrylate)-based bone cement. Indicated for fixation of endoprostheses in arthroplasty surgery of the hip and knee if an infection with organisms, that are sensitive to gentamicin, is diagnosed or suspected.
Functional description
Hi-Fatigue G Bone Cement is used to anchor prosthetic implants to bone. It contains the antibiotic gentamicin sulfate, which helps prevent bacterial colonisation on the implant surface and surrounding tissue. The system consists of two components, a powder and a liquid, which when mixed form a workable paste. This paste is applied during surgery to secure the prosthesis to the bone, where it subsequently hardens in situ.