Device Dossier

MODULAR SLEEVE 12/14 for revision head - Femoral head/stem prosthesis adaptor

Device Dossier for MODULAR SLEEVE 12/14 for revision head - Femoral head/stem prosthesis adaptor (Femoral head/stem prosthesis adaptor, Class III,…

Intended purpose

A modular adaptor sleeve component combined with a ceramic revision femoral head designed to be used in total hip arthroplasty (THA)revisions. Indications for use are; - Primary and secondary arthrosis - Rheumatoid and degenerative arthritis - Deformities, such as dysplasia - Fractures and necrosis of bone - Revisions, where other devices or treatments have failed - Metastatic diseases

Functional description

A titanium metal adaptor sleeve with a 12/14 inner taper for use with ceramic revision femoral heads to attach the head to the trunnion of a femoral stem (or trunnion of a modular neck).

TGA Public Summary