MOTO PARTIAL KNEE SYSTEM - MEDIAL

Description of Event or Problem

THE PATIENT UNDERWENT PRIMARY RIGHT KNEE SURGERY ON (B)(6) 2025. ON (B)(6) 2026, THE PATIENT PRESENTED WITH SIGNS OF INFECTION, WITH AN UNKNOWN PATHOGEN. A WASHOUT WAS PERFORMED, AND THE S4-H8 MOTO INSERT WAS REVISED TO AN INSERT OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2026, THE PATIENT PRESENTED WITH CONTINUED SIGNS OF INFECTION, WITH AN UNKNOWN PATHOGEN. A FURTHER WASHOUT WAS PERFORMED, ALL MOTO IMPLANTS WERE REVISED, AND ARTICULATING ANTIBIOTIC SPACERS WERE IMPLANTED. THE PATIENT`S NATURAL PATELLA WAS ALSO RESURFACED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEWS PERFORMED ON 23 JUNE 2026: MOTO PARTIAL KNEE 02.18.003RM MOTO MEDIAL FEMORAL COMPONENT S3 RM (K103721) LOT 2428576: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2025. EXPIRATION DATE: 04-DEC-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.EIF4.08.RM MOTO MEDIAL E-CROSS TIBIAL INSERT S4 RM - H8 (K213071) LOT 2311657: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-AUG-2023. EXPIRATION DATE: 18-JUL-2028. 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.TF4.RM MOTO MEDIAL TIBIAL TRAY S4 RM (K162084) LOT 2419731: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEP-2024. EXPIRATION DATE: 16-SEP-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.