Device Dossier
Persona® Revision Stem Extension, Splined - Knee stem
Device Dossier for Persona® Revision Stem Extension, Splined - Knee stem (Knee stem, Class III, sponsor Zimmer Biomet). ARTG record, intended purpose,…
- GMDN category: Knee stem
Intended purpose
The Persona Revision Stem Extension, Splined is a component of the Persona Revision Knee System, which is a constrained revision knee prosthesis system. This device is indicated for patients with severe knee pain and disability due to: • Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Collagen disorders, and/or avascular necrosis of the femoral condyle. • Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. • Moderate valgus, varus, or flexion deformities. • The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Functional description
Splined Stems are designed for femoral/tibial use and are available in a variety of lengths and diameters, and straight (0mm) and offset variations (3mm,6mm). They feature splines that are designed to provide increased rotational stability via press fit with the host bone. Offset stems allow 360° of translation of the femoral and/or tibial component position in cases where the medullary canal is not coaxial with the stem housing of the tibial/femoral component. Intended to be used uncemented.