FX V135 Mini
Received Jul 31, 2026 · Event occurred Jul 23, 2026
Report 3014128390-2026-00038 · MDR key 50106887
Device
Generic name
Reverse Shoulder Prosthesis
Manufacturer
Fx Shoulder Solutions DallasCatalog number
105-4010
Lot number
V2464
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Joint Laxity
Narrative
Description of Event or Problem
Revision was performed on (b)(6) 2026 approximately 366 days after the primary surgery which happened on (b)(6) 2025. No fall or other trauma was reported. Based on the information available, only HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø40mm and HUMERAL CUP STABILITY PE/TA6V Ø40/+6 due to instability. FX V135® HUMELOCK STEM TA6V Ø40/12 L. 120MM CEMENTLESS Ti/HA was not replaced.
Additional Manufacturer Narrative
Revision occurred approximately 366 days after the primary surgery due to instability. No actual, implied or suspect link to FX product.