INHANCE

Description of Event or Problem

SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POOR ACTIVE MOTION, POSSIBLE AXILLARY NERVE INJURY DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NOT RELATED, PROCEDURE RELATED: POSSIBLE, DATE OF EVENT: (B)(6) 2026, DATE OF IMPLANT: (B)(6) 2026, DATE OF REVISION: NO INTERVENTION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION: YES, SPECIFY: NCV/EMG. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550036100, LOT NUMBER: MI191184, COMPONENT TYPE: LINER, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310015, LOT NUMBER: 230230, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550000360, LOT NUMBER: 661634, COMPONENT TYPE: SHELL, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550536104, LOT NUMBER: 351208, COMPONENT TYPE: GLENOSPHERE, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 520000036, LOT NUMBER: 662988, COMPONENT TYPE: HUMERAL, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310030, LOT NUMBER: 239924, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310020, LOT NUMBER: 219917, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550025600, LOT NUMBER: 234397, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550011240, LOT NUMBER: 665007, COMPONENT TYPE: BASEPLATE, UNIQUE DEVICE ID: (B)(4).

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.