Device Dossier
MUTARS humerus head silver - Humeral head prosthesis
Device Dossier for MUTARS humerus head silver - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Life Healthcare). ARTG record,…
- GMDN category: Humeral head prosthesis
Intended purpose
A component of the MUTARS system intended to replace the humeral head as part of a proximal or total humerus reconstruction. Primary indication for the use of the MUTARS systems is after bone resection because of a tumour. Further indications for the use of the MUTARS systems are massive bone loss such as in Morbus Gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis. The silver coated surface builds a long term prophylaxis against the colonisation of human pathogenic bacteria such as staphylococcus aureus and epidermis, exclusive enterobacteriae and should not be considered as acute treatment.
Functional description
Composed of TiAl6V4. An all extraosseous part that has a sand blasted surface & provides a silver coating applied circumferentially. Uses the cylindrical fit & serration connection for attachment to the connecting part, extension piece & a femoral stem. Six holes at the proximal part of the head are used for securing a PET mesh soft tissue attachment tube. The thread at the proximal part serves for connecting with the MUTARS Humerus Cap and MUTARS Humerus Cap inverse respectively.