DELTA XTEND
Received Jun 8, 2026 · Event occurred May 13, 2026
Report 1818910-2026-09828 · MDR key 25433253
Device
Generic name
Delta Xtend Implants : Shoulder Metaglene
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
130760000
Lot number
4557065
Product problems
- Device Dislodged or Dislocated
Patient
71 YR · Male
- Unspecified Musculoskeletal problem
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT HAS HAD MULTIPLE FALLS AND THE GLENOSPHERE DISASSOCIATED FROM THE BASE PLATE. POLY WAS DEFORMED FROM RUBBING AGAINST BASEPLATE. DOCTOR DECIDED THAT A CTA HEAD WOULD BE THE BEST CHOICE FOR THIS PATIENT. TOOK OUT POLY, GLENOSPHERE, BASEPLATE, AND SCREWS AND REPLACED WITH THE CTA HEAD. IT WAS STATED THAT THE LOOSENING OF SHOULDER GLENOSPHERE WAS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2026 AFFECTED SIDE: UNKNOWN.
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. ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.