SHOULDER HUMERAL STEM
Received Jul 9, 2026 · Event occurred Jun 25, 2026
Report 1818910-2026-11647 · MDR key 25758265
Device
Generic name
Shoulder Humeral Stem
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
UNK SHOULDER HUMERAL STEM GLOB
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
64 YR · Male
- Unspecified Tissue Injury
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT REVISED DUE TO FAILED ROTATOR CUFF. DONE IN 2016. DOI-(B)(6) 2016; DOR-(B)(6) 2026; AFFECTED SIDE- RIGHT SHOULDER.
Additional Manufacturer Narrative
"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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE."