EASYTECH
Received Jun 24, 2026 · Event occurred Jun 8, 2026
Report 3009532798-2026-00028 · MDR key 25607016
Device
Generic name
Anatomic Shoulder Prosthesis
Manufacturer
Fx Shoulder SolutionsCatalog number
314-0038
Lot number
W0121
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Joint Laxity
Narrative
Additional Manufacturer Narrative
THE EVENT TOOK PLACE OUTSIDE THE UNITED STATES (IN FRANCE) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET IN THE UNITED STATES.
Description of Event or Problem
THE PATIENT WAS REVISED DUE TO LOOSENING ON (B)(6) 2026? IT IS EVIDENTLY AN ISSUE WITH THE INITIAL POSITIONING OF THE IMPLANTS THAT LIKELY CAUSED EXCESSIVE STRESS AND, ULTIMATELY, LOOSENING OF THE PROSTHETIC GLENOID COMPONENT. THE IMPLANTATION DATE WAS ON (B)(6) 2025. AN EASYTECH ANCHOR BASE, AN EXCENTRIC HEAD, A 2 PEGS GLENOID AND A DOUBLE TAPER WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS, A POST EXTENSION AND A STEM WERE IMPLANTED.