INHANCE
Received Jul 22, 2026 · Event occurred Jun 29, 2026
Report 1818910-2026-12514 · MDR key 25908303
Device
Generic name
Shoulder Implant - Humeral Anchor
Manufacturer
Depuy Ireland - 3015516266Catalog number
520000036
Lot number
662988
Product problems
- Osseointegration Problem
Patient
Not reported
- Inadequate Osseointegration
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 THAT STEMLESS COMPONENT FAILED. THERE WAS LOOSENING OF STEMLESS COMPONENT TO BONE AT NON CEMENTED INTERFACE. PATIENT WAS REVISED TO STEMMED SHOULDER. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN SHOULDER.