MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 03 JULY 2026 LOT 2516315: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 JULY 2025. EXPIRATION DATE: 23 JUNE 2030. 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 2 MONTHS FROM FIRST REVISION SURGERY. THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2024. THE SURGEON REVISED THE COMPETITOR LINER AND THE MEDACTA 36MM BIOLOX HEAD S WAS REVISED TO A 36 MM BIOLOX OPTION HEAD WITH SLEEVE.