Device Dossier

Copal G+V - Cement, orthopaedic, bone

Device Dossier for Copal G+V - Cement, orthopaedic, bone (Cement, orthopaedic, bone, Class III, sponsor Heraeus Medical). ARTG record, intended purpose,…

Intended purpose

COPAL G+V is intended for filling and/or stabilising bone cavities and allows the permanent fixation of joint endoprostheses in surgically cleaned bone cavities which were previously infected by pathogens sensitive to vancomycin and when solely gentamicin-containing cement is considered inadequate or undesirable during single-stage and two-stage replacement procedures. COPAL G+V is a revision cement that should only be used if the pathogens responsible for the infection are not sufficiently sensitive towards the aminoglycoside antibiotics or combinations of aminoglycoside and lincosamide antibiotics contained in PMMA revision cements.

Functional description

A fast-curing, cementitious polymethyl methacrylate-based resin containing the contrast medium zirconium dioxide. Addition of antibiotics gentamicin and vancomycin provides protection against infection due to contamination of the cured cement and contiguous tissue with pathogens sensitive to these antibiotics. After mixing, a plastic dough is obtained which is filled into the bone as an anchoring medium. The cement which then hardens in the bone allows stable fixation of the endoprostheses.

TGA Public Summary