Device Dossier
Synicem Evolution Knee Spacer with Gentamicin - Cement, orthopaedic, bone spacer
Device Dossier for Synicem Evolution Knee Spacer with Gentamicin - Cement, orthopaedic, bone spacer (Cement, orthopaedic, bone spacer, Class III, sponsor…
- GMDN category: Cement, orthopaedic, bone spacer
Intended purpose
Synicem Evolution Knee Spacer with Gentamicin is a temporary implant which main function is to preserve the articular space during a Two Stage Revision Arthroplasty. Furthermore it also aids in the treatment of the infection that emerged due to the implant of the knee prosthesis. This procedure consists of first stage during which the infected prosthesis is removed and the spacer is implanted. During the second stage, once the patient has finished the specific treatment and no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis.
Functional description
SYNICEM Evolution Knee Spacer with Gentamicin use is indicated for a limited period, in patients with an infection due to gentamicin-sensitive pathogen, 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.