DELTA XTEND
Received Jun 26, 2026 · Event occurred Jun 4, 2026
Report 1818910-2026-10929 · MDR key 25634243
Device
Generic name
Delta Xtend Implants : Shoulder Glenosphere
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
130760142
Lot number
5312335
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED A REVISION OF A DELTA XTEND CASE OCCURRED ON (B)(6) 2026 DUE TO INFECTION. THE DELTA XTEND GLENNOSHERE AND DELTA XTEND HUMERAL PE CUP WERE EXCHANGED. TISSUE SAMPLES AND SWABS TAKEN FOR INFECTION ANALYSIS. NO SURGICAL DELAY. ORIGINAL SURGERY DATE 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.