MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 16 JUNE 2026 BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT 2524330: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2025. EXPIRATION DATE: 22-SEP-2030. 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. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER D 36/E (K103721) LOT 2534780: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-FEB-2026. EXPIRATION DATE: 29-JAN-2031. 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

AT ABOUT 1 MONTH FROM THE PRIMARY,THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON OBSERVED WOUND WEEPING AND PERFORMED A WASHOUT. DURING THE PROCEDURE, THE HEAD WAS REVISED TO A HEAD WITH A SLEEVE, AND THE LINER WAS REVISED TO A SAME-SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.