MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 23 JUNE 2026 BALL HEADS: MECTACER 01.29.213 MECTACER HEAD BIOLOX DELTA DIA.40 12/14-M (K112115) LOT 2602766: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-FEB-2026. EXPIRATION DATE: 11-FEB-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. LINER: MPACT 01.32.4048HCT FLAT PE HC LINER D 40/F (K103721) LOT 2528038: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JAN-2026. EXPIRATION DATE: 25-NOV-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. 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 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLAT PE HC LINER D 40/F TO A FACE CHANGING 10° PE HC LINER D 40/G AND THE 40MM BIOLOX HEAD M TO A SIZE S. THE SURGERY WAS COMPLETED SUCCESSFULLY.