DELTA XTEND
Received Jul 8, 2026 · Event occurred Jun 15, 2026
Report 1818910-2026-11584 · MDR key 25746275
Device
Generic name
Delta Xtend Implants : Shoulder Humeral Cup
Manufacturer
Depuy Ireland - 9616671Catalog number
130738106
Lot number
5364385
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Pain
- Loss of Range of Motion
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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED A REVISION OF REVERSE SHOULDER REPLACEMENT OCCURRED DUE TO PAIN AND LACK OF RANGE OF MOTION. ONLY COMPONENT REMOVED AND CHANGED WAS THE LINER. SWABS WERE TAKEN DURING THE CASE TO RULE OUT INFECTION. NO SURGICAL DELAY.