EQUINOXE, HUMERAL LONG STEM 8MM 175MM
Received Apr 15, 2026 · Event occurred Feb 21, 2018
Report 1038671-2026-00438 · MDR key 24889107
Device
Generic name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Manufacturer
Exactech, Inc.Catalog number
306-01-08
Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
51 YR · Female
- Pain
- Nonunion/Delayed-union Bone Fracture
- Aseptic loosening
Narrative
Additional Manufacturer Narrative
THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED VIA CLINICAL THAT THIS PATIENT UNDERWENT A SHOULDER REPLACEMENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED SHOULDER PAIN ATTRIBUTED TO HUMERAL COMPONENT LOOSENING AND NONUNION. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE HUMERAL STEM, HUMERAL TRAY, AND HUMERAL LINER WERE REVISED. THE OUTCOME IS CONSIDERED RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.