EQUINOXE
Received Apr 14, 2026 · Event occurred Mar 16, 2026
Report 1038671-2026-00428 · MDR key 24880290
Device
Generic name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Manufacturer
Exactech, Inc.Catalog number
300-01-10
Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
80 YR · Female
- Aseptic loosening
Narrative
Additional Manufacturer Narrative
D10: 320-42-13 - EQ RE 42MM HUMERAL CONST LINER +2.5: (B)(6), 320-10-00 - EQ REV TRAY ADAPTER PLATE TRAY +0: (B)(6), 320-02-42 - RS EXP GLENOSPHERE 42MM, +4MM OFFSET: (B)(6), 320-15-01 - EQ REV GLENOID PLATE: 57: (B)(6), 320-15-05 - EQ REV LOCKING SCREW: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED VIA A CLINICAL STUDY, THAT A PATIENT, WHO HAD A RTSA, UNDERWENT A REVISION PROCEDURE. THE STUDY INDICATED A POSSIBLE LOOSE STEM. ASEPTIC HUMERAL LOOSENING. UNLIKELY RELATED TO THE DEVICE OR THE PROCEDURE. THE SURGEON REMOVED THE STANDARD HUMERAL STEM. THE OUTCOME STATES RESOLVED. NO FURTHER INFORMATION.