INHANCE
Received Jun 26, 2026 · Event occurred Jun 3, 2026
Report 1818910-2026-10973 · MDR key 25637813
Device
Generic name
Shoulder Implant - Locking Screw
Manufacturer
Depuy IrelandCatalog number
550300500
Lot number
236045
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
70 YR · Female
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO R/SPEED BASEPLATE AND GLENOSPHERE LOOSENING. PATIENT¿S GLENOID FRACTURED, CAUSING THE BASEPLATE AND GLENOSPHERE TO SHIFT ANTERIORLY. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.