EQUINOXE
Received Apr 7, 2026 · Event occurred Mar 10, 2026
Report 1038671-2026-00398 · MDR key 24811840
Device
Generic name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Manufacturer
Exactech, Inc.Catalog number
314-02-14
Product problems
- Naturally Worn
Patient
65 YR · Male
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
D10: 300-01-17 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 17MM (B)(6); 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S (B)(6); 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT (B)(6); 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA) (B)(6); SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A LEFT ANATOMIC IMPLANT CONSTRUCT AND PRESENTED TO THE SURGEON¿S OFFICE WITH SIGNS AND SYMPTOMS OF AN INFECTION. THE PATIENT WAS SCHEDULED FOR AN EXCISION/ REMOVAL OF THE TOTAL SHOULDER ARTHROPLASTY AND PLACEMENT OF AN ANTIBIOTIC SPACER. THE PATIENT UNDERWENT THE PROCEDURE AND THE IMPLANTS WERE REMOVED, AND AN ANTIBIOTIC SPACER WAS PLACED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY IMAGING WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.