SHOULDER SYSTEM

Additional Manufacturer Narrative

BATCH REVIEWS PERFORMED ON 6 JULY 2026: REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE - D 36X24.5 (K170452) LOT 2522793: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2025. EXPIRATION DATE: 21-OCT-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0400 GRS BASEPLATE - D 24.5X20 - FULL WEDGE 10° (K231911) LOT 2413744: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2024. EXPIRATION DATE: 23-OCT-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: BASED ON THE INFORMATION PROVIDED, THE PATIENT PRESENTED WITH PAIN DUE TO THE DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE, WITH NO REPORTED TRAUMA OR FALL. A REVIEW OF THE AVAILABLE INFORMATION DOES NOT IDENTIFY THE UNDERLYING CAUSE. DISASSOCIATION AT THE GLENOSPHERE-BASEPLATE INTERFACE IS MOST COMMONLY ASSOCIATED WITH INCOMPLETE ENGAGEMENT OR SUBOPTIMAL SEATING OF THE MORSE TAPER AT THE TIME OF IMPLANTATION — INCLUDING INTERPOSITION OF SOFT TISSUE, BONE, OR FLUID AT THE INTERFACE, OR INSUFFICIENT IMPACTION WHICH MAY LEAD TO COMPONENT DISASSOCIATION UNDER PHYSIOLOGICAL LOADING IN THE ABSENCE OF TRAUMA. WITH THE ELEMENTS CURRENTLY AVAILABLE, NO DEFINITIVE CONCLUSION REGARDING A DEVICE MALFUNCTION CAN BE DRAWN. INVESTIGATION PERFORMED BY MEDACTA SHOULDER R&D PROJECT MANAGER: THE PATIENT REPORTED PAIN, AND REVISION SURGERY CONFIRMED GLENOSPHERE DISASSOCIATION FROM THE BASEPLATE. NO TRAUMA OR FALL WAS REPORTED. THE DEDICATED WIRE GUIDE WAS REPORTEDLY NOT USED DURING ASSEMBLY; THIS MAY HAVE CONTRIBUTED TO INCOMPLETE OR INCORRECT POSITIONING OF THE GLENOSPHERE, ALTHOUGH NO DIRECT EVIDENCE IS AVAILABLE TO CONFIRM THIS HYPOTHESIS. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. ROOT CAUSE:BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. INCOMPLETE SEATING OR SUBOPTIMAL ENGAGEMENT OF THE MORSE TAPER DURING IMPLANTATION MAY HAVE CONTRIBUTED TO THE EVENT, POTENTIALLY ASSOCIATED WITH THE REPORTED NON-USE OF THE DEDICATED WIRE GUIDE; HOWEVER, THIS HYPOTHESIS CANNOT BE CONFIRMED. THE BATCH REVIEWS DID NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

Description of Event or Problem

THE PATIENT HAD PAIN DUE TO THE GLENOSPHERE DISASSOCIATING FROM THE BASEPLATE AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA OR A FALL. AT ABOUT 2 MONTHS POST PRIMARY THE SURGEON REVISED THE GLENOSPHERE TO A SAME SIZE GLENOSPHERE.THE WIRE GUIDE WAS NOT USED DURING THE PRIMARY TO ASSEMBLE THE GLENOSPHERE TO THE BASEPLATE. THE CORRECT TORQUE SCREWDRIVER WAS USED TO TIGHTEN THE GLENOSPHERE SCREW.THE SURGERY WAS COMPLETED SUCCESSFULLY.