8.0MM X 8.0MM STEM

Description of Event or Problem

IT WAS REPORTED ON 7/23/2024 A NURSE FOUND AN 8.0MM X 8.0MM STEM (PART NUMBER TR-S0808-S, BATCH NUMBER 416868) WAS EXPIRED (EXPIRATION DATE: 7/20/2024). THE SURGEON WAS NOTIFIED OF THE EXPIRED STEM BEFORE THE STEM WAS IMPLANTED AND CHOSE TO MOVE FORWARD WITH THE SURGERY. THE SURGEON AND THE NURSE IN THE SURGERY SIGNED OFF ON THE STEMS USAGE ON THE DATE IT WAS DETECTED. THE SURGERY WAS COMPLETED IN STANDARD FASHION WITH NO DELAY. THE NURSE SIGNED THE PAPERWORK FOR THE CASE AND THE FACILITY WAS NOTIFIED OF THE OCCURRENCE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED FOR 8.0MM X 8.0MM STEM (PART NUMBER TR-S0808-S, BATCH 416868), AND NO ANOMALIES WERE FOUND. THE MANUFACTURING RECORDS INDICATED THE STEM EXPIRED 7/20/2024. BASED ON THE INFORMATION RECEIVED, THE FACILITY IMPLANTED EXPIRED PRODUCT IN THE PATIENT.