INHANCE SHOULDER SYSTEM STEMLESS MEDIUM DIAMETER 36MM CEMENTLESS

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.

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5. CORRECTED: H6 (HEALTH EFFECT - IMPACT CODE). 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

ADDITIONAL INFORMATION RECEIVED: TREATMENT: SURGICAL INTERVENTION FOR THE STUDY SHOULDER: YES ((B)(6) 2026). SINGLE-STAGE REVISION: YES. ANY NEW COMPONENTS IMPLANTED? YES. IF YES, SPECIFY: HUMERAL STEM IMPLANT, REVERSE HUMERAL SHELL, AND REVERSE LINER.

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

SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LOOSE STEMLESS HUMERAL STUDY IMPLANT DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 09 MAR 2026. DATE OF IMPLANT: (B)(6) 2026. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. DEVICE RELATED: PROBABLE. PROCEDURE RELATED: PROBABLE. TREATMENT/IMPACT: RESULTED IN MEDICAL OR SURGICAL INTERVENTION (STUDY SHOULDER), HUMERAL STEMLESS IMPLANT: YES DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520000036. LOT NUMBER: 662705. COMPONENT TYPE: HUMERAL. DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS MEDIUM DIAMETER 36MM CEMENTLESS. CATALOG NUMBER: 550515290. LOT NUMBER: 664835. COMPONENT TYPE: BASEPLATE. DESCRIPTION: INHANCE SHOULDER SYSTEM R/SPEED UNITI PLATFORM BASEPLATE LARGE Ø29MM CEMENTLESS. CATALOG NUMBER: 550300500. LOT NUMBER: 235420. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20MM & 25MM. CATALOG NUMBER: 550540004. LOT NUMBER: 356726. COMPONENT TYPE: GLENOSPHERE. DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø40+4MM. CATALOG NUMBER: 550000360. LOT NUMBER: 664537. COMPONENT TYPE: SHELL. DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE HUMERAL SHELL MEDIUM Ø36+0MM. CATALOG NUMBER: 550040100. LOT NUMBER: MI158308. COMPONENT TYPE: LINER. DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE LINER RETENTIVE X-LINKED VITAMIN E PE Ø40+0MM.