STEMLESS L 40

Description of Event or Problem

SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR WORSENING BILATERAL SHOULDER PAIN DEVICE RELATED: NOT RELATED PROCEDURE RELATED: POSSIBLE DATE OF EVENT: 19 NOV 2025 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT TREATMENT/IMPACT: REHABILITATION, INJECTED MEDICATION (TRIAMCINOLONE (KENALOG-40) INJECTION 20-120 MG) DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520000040 LOT NUMBER: 662039 COMPONENT TYPE: HUMERAL DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS LARGE DIAMETER 40MM CEMENTLESS CATALOG NUMBER: 550011240 LOT NUMBER: 663949 COMPONENT TYPE: BASEPLATE DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS CATALOG NUMBER: 550300500 LOT NUMBER: 220085 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20MM & 25MM CATALOG NUMBER: 550035600 LOT NUMBER: 217704 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM CATALOG NUMBER: 550532008 LOT NUMBER: 345531 COMPONENT TYPE: GLENOSPHERE DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø32+8MM CATALOG NUMBER: 550000400 LOT NUMBER: 664523 COMPONENT TYPE: SHELL DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE HUMERAL SHELL LARGE Ø40+0MM CATALOG NUMBER: 550032100 LOT NUMBER: MI169614 COMPONENT TYPE: LINER DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE LINER RETENTIVE X-LINKED VITAMIN E PE Ø32+0MM.

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. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

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: 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 MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. H11 ADDITIONAL NARRATIVE: ADDED: D10.