InjuryKWS
EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
Received Jul 20, 2026 · Event occurred Jul 24, 2024
Report 1038671-2026-00920 · MDR key 25882486
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Exactech, Inc.Catalog number
300-01-11
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR · Male
- Bone Fracture(s)
Narrative
Description of Event or Problem
IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT WHO HAD A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, WAS REPORTED TO HAVE A MIDSHAFT HUMERAL FRACTURE WHICH OCCURRED INTRAOPERATIVELY. THE PERIPROSTHETIC FRACTURE AROUND THE HUMERUS WAS FIXED WITH CERCLAGE FIBRETAPE FIXATION. THE CORACOID TIP AVULSION FRACTURE WAS REPORTED TO BE NOT REPAIRABLE. THE AVULSION FRACTURE WAS DUE TO TRACTION FROM RETRACTORS, WHICH WAS NOTED AT THE END OF THE CASE. THE OUTCOME IS CONSIDERED TO BE RESOLVED.