MOTO PARTIAL KNEE SYSTEM - MEDIAL

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 09 APRIL 2026 MOTO PARTIAL KNEE 02.18.003RM MOTO MEDIAL FEMORAL COMPONENT S3 RM (K162084) LOT. 2407825 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2024. EXPIRATION DATE: 02-MAY-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 35 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.TF3.RM MOTO MEDIAL TIBIAL TRAY S3 RM (K162084) LOT. 2422900 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2024. EXPIRATION DATE: 09-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. MOTO PARTIAL KNEE 02.18.EIF3.08.RM MOTO E-CROSS TIBIAL INSERT S3 H8 RM (K213071) LOT. 2426262. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2024. EXPIRATION DATE: 22-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. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

Description of Event or Problem

REVISION SURGERY PERFORMED DUE TO INFECTION, 9 MONTHS AFTER THE PREVIOUS REVISION DUE TO INFECTION (MDR 2025-00628). THE SURGEON REMOVED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY, AND IMPLANTED ANTIBIOTIC SPACERS IN THE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.