EQUINOXE STEMLESS HUMERAL COMPONENT
Received Aug 14, 2025 · Event occurred Jul 21, 2025
Report 1038671-2025-02756 · MDR key 22803798
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No
Manufacturer
Exactech, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
77 YR · Female
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
D10: 300-60-01 - STEMLESS HUM COMP LASER CAGE, SIZE 1: (B)(6), 310-62-41 - STEMLESS HUM HEAD 41MM X 13MM X ALPHA: (B)(6), 314-23-02 - LASER CAGE GLEN SMALL, ALPHA: (B)(6). 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 THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. APPROXIMATELY 32 MONTHS POST-OP, THE PATIENT LIFTED AN OBJECT AND EXPERIENCED SEVERE PAIN IN THE RIGHT NECK, SHOULDER, AND HAND. A DIAGNOSIS OF CERVICAL RADICULITIS WAS GIVEN. THE ISSUE WAS RESOLVED WITH A CERVICAL EPIDURAL INJECTION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.