Device Dossier

Synicem Hip Spacer with Gentamicin - Cement, orthopaedic, bone spacer

Device Dossier for Synicem Hip Spacer with Gentamicin - Cement, orthopaedic, bone spacer (Cement, orthopaedic, bone spacer, Class III, sponsor LC &…

Intended purpose

The gentamicin hip spacer is a temporary (maximum 180 days) implant whose primary function is to maintain joint space during two-stage revision arthroplasty and whose secondary function is to assist in the treatment of the joint infected by gentamicin-sensitive pathogen. This procedure consists of a first step in which the infected prosthesis is removed, followed by placement of the spacer. In a second step, when the patient has completed the specific treatment, and in the absence of signs of infection, the spacer is removed and the new definitive prosthesis is fitted.

Functional description

Synicem Hip Spacer with Gentamicin use is indicated for a limited period, in patients with an infection due to gentamicin sensitive pathogens, who require a Two-stage Revision Arthroplasty. Together with the spacer, the use of systemic antibiotic therapy is recommended. The Spacer is placed as a hermiarthroplasty after the original implant is removed.

TGA Public Summary