INHANCE
Received Apr 27, 2026 · Event occurred Apr 10, 2026
Report 1818910-2026-07619 · MDR key 24999919
Device
Generic name
Shoulder Implant - Shoulder Glenoid
Manufacturer
Depuy Ireland - 3015516266Catalog number
510029022
Lot number
MI150366
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
78 YR · Male
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORM. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT- THERE IS NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. ADDED: D10 (CONCOMITANT).
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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT AFTER THE INITIAL SURGERY THE PATIENT UNFORTUNATELY SUFFERED FROM ROTATOR CUFF FAILURE AND THEIR SHOULDER NEEDED TO BE CONVERTED. THE HUMERAL HEAD, ANATOMIC ADAPTER, AND HYBRID GLENOID WERE REMOVED. GLENOID WAS THEN PREPPED FOR A REVERSE BASEPLATE AND GLENOSPHERE. HUMERAL SIDE WAS THEN CONVERTED TO A HUMERAL SHELL AND POLY. STABILITY OF THE SHOULDER WAS CONFIRMED WITH TRIAL COMPONENTS BEFORE DEFINITIVE IMPLANTS WERE OPENED AND IMPLANTED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES. AFFECTED SIDE: RIGHT.