DELTA XTEND
Received Jun 8, 2026 · Event occurred May 13, 2026
Report 1818910-2026-09844 · MDR key 25436177
Device
Generic name
Delta Xtend Implants : Shoulder Glenosphere
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
130760038
Lot number
5866843
Product problems
- Difficult to Insert
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
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.
Description of Event or Problem
IT WAS REPORTED THAT THE SURGEON COULD NOT IMPLANT. THE DEVICE WAS STRIPPED, AND THE IMPLANT WAS WASTED. THE HOSPITAL HAS DISPOSED OF IT. AFFECTED SIDE: LEFT SHOULDER.