EQUINOXE
Received Jul 6, 2026 · Event occurred Jun 15, 2026
Report 1038671-2026-00849 · MDR key 25725611
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Exactech, Inc.Catalog number
314-02-33
Product problems
- Naturally Worn
Patient
NA · Male
- Erosion
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT, WHO HAD RIGHT TSA UNDERWENT A 1ST STAGE REVISION PROCEDURE. BASED ON THE CT SCAN, IT APPEARS THAT THE HUMERAL HEAD WAS NO LONGER FULLY ARTICULATING ON THE POLY GLENOID AND HAS ERODED INTO THE POSTERIOR ASPECT OF THE GLENOID. THE 2ND STAGE WILL BE A CUSTOM-MADE GLENOID COMPONENT OWING TO THE SEVERITY OF BONE LOSS, RETAINING THE HUMERAL STEM. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGE DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.