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TGA Action ID	RC-2025-RN-00508-1
Type of Product	Medical Device
Product Name/Description	MUTARS Proximal Femur and MUTARS Proximal Femur Revision systems Product codes: 5710205, 5710207, 57100205S, 57100207S, 5710305, 5710307, 5710405, 5710407, 57100305S, 57100307S, 57100405S and 57100407S All sizes All batches Supplied via the ARTG and the Special Access Scheme (SAS)
ARTG Number	227163, 284591, 319680
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	The Instructions for Use (IFU) and Surgical Technique (ST) documents are being updated for all instruments and sizes of the MUTARS proximal femur and MUTARS proximal femur revision. Additional limits of use were specified in particular for the MUTARS proximal femur (revision) devices as part of a hip arthroplasty involving transition to the MDR certification. As part of the MUTARS proximal femur (revision) system's certification in accordance with the new European Regulation MDR (EU) 2017/745, additional finite element analyses were conducted which simulate the endurance tests in accordance with ISO 7206-4. The simulation results have prompted the manufacturer to stipulate limits of use for some products and sizes. This update represents a precautionary restriction on the area of use based on the results of a worst-case simulation. This decision is not due to a safety problem with the implants. There is no increased risk to patients based on the actual failure rates of the scenarios.
Instructions for Customers/Users	Customers are to: · Be notified of the safety-related updates to the Instructions for Use (IFU) and Surgical Technique (ST) documents for the MUTARS proximal femur and MUTARS proximal femur revision systems. · Continue routine follow-up for patients with existing implantations, as no special follow-up measures are required. · Consult the updated IFU and ST documents on an ongoing basis to ensure adherence to the latest safety information and usage recommendations. This action has been closed out on 29/10/2025
Action Commencement Date	27/06/2025
Responsible Entity	Life Healthcare Pty Ltd
Contact Information	1800 060 168 – Life Healthcare Customer Service