Device Dossier

METS Proximal Tibial Fixed Hinge, plain c/w bumper - Uncoated knee tibia prosthesis, metallic

Device Dossier for METS Proximal Tibial Fixed Hinge, plain c/w bumper - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis,…

Intended purpose

The Proximal Tibia Fixed Hinge, plain is a component of the METS Proximal Tibial Modular System which is designed as a modular system that can be used to replace diseased or deficient bone in the proximal tibia. The indications for this modular massive endoprosthetic system are: • Primary bone tumours • Secondary tumours arising in bone • Non-neoplastic conditions affecting the shafts of long bones • Failed joint replacements • Failed massive replacements"

Functional description

The Proximal Tibia Fixed Hinge, plain is an uncoated CoCrMo proximal tibial component with an UHMWPE bumper which provides a secondary bearing surface and a soft hyperextension stop.It is chosen for cases with significant loss of soft tissue function and where additional constraint is required. The assembly sequence should be tibial component onto the shaft stem/stem construct followed by the collar if using the 30mm integral construct. The tibial assembly is then inserted into the tibia.

TGA Public Summary