INHANCE
Received Jun 22, 2026 · Event occurred May 28, 2026
Report 1818910-2026-10591 · MDR key 25577840
Device
Generic name
Shoulder Implant - Humeral Cup
Manufacturer
Depuy Ireland - 3015516266Catalog number
550036000
Lot number
MI196305
Product problems
- Device Dislodged or Dislocated
Patient
Not reported
- Joint Dislocation
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 THE PATIENT HAD A CHRONIC DISLOCATION A COUPLE MONTHS AFTER SURGERY. DR FOUND IT BEST TO REMOVE THE GLENOSPHERE/POLY AND INCREASE FROM A 36 TO A 40 TO HELP WITH THIS PROBLEM. THERE WAS NO MORE INFORMATION AVAILABLE AT THIS TIME. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.