M-VIZION FEMORAL REVISION SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 01 JULY 2026 M-VIZION 01.22.103 DISTAL STEM D 14MM L 140MM STRAIGHT (K170690) LOT. 2337343: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2024. EXPIRATION DATE: 2029-JAN-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. MPACT 01.26.2850MHC DOUBLE MOBILITY HC LINER D 28/DME (K092265) LOT. 2421335: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-SEP-2024. EXPIRATION DATE: 2029-SEP-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MECTACER 01.29.202 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M (K112115) LOT. 2427352: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2024. EXPIRATION DATE: 2029-SEP-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. MPACT 3D METAL 01.38.062MH MPACT 3D METAL SHELL MULTI HOLE D 62MM (K171966) LOT. 2011329: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2021. EXPIRATION DATE: 2026-APR-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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 DUE TO INFECTION AFTER ABOUT 1 YEAR AND 1 MONTH FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.