UNKNOWN SHOULDER GLENOID
Received Jul 9, 2026 · Event occurred Jun 10, 2026
Report 1818910-2026-11665 · MDR key 25760495
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Depuy Ireland - 9616671Catalog number
UNK SHOULDER GLENOID
Product problems
- Osseointegration Problem
Patient
NA · Unknown
- Inadequate Osseointegration
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE ANATOMIC GLENOID AT THE BONE TO IMPLANT INTERFACE. THE GLENOID IMPLANT WAS COMPLETELY LOOSE AND FLOATING BEHIND THE JOINT. IT WAS ALSO REPORTED THAT THE GLENOID DISASSOCIATED. AFFECTED SIDE: RIGHT SHOULDER.