inforMED
InjuryHSD

EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM

Received Jun 10, 2026 · Event occurred May 19, 2026

Report 1038671-2026-00758 · MDR key 25461236

Device

Generic name

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Manufacturer

Exactech, Inc.

Catalog number

300-01-09

Product problems

  • Loosening of Implant Not Related to Bone-Ingrowth

Patient

NA · Male

  • Unspecified Infection

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THIS PATIENT UNDERWENT A RIGHT SHOULDER REPLACEMENT. SUBSEQUENTLY, THEY PATIENT DEVELOPED A LOW-GRADE INFECTION CAUSING IMPLANT LOOSENING. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.