MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 24 JUNE 2026: BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT 1900806: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 23-APR-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3652HCT FLAT PE HC LINER D 36/G (K103721) LOT 186973: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2018. EXPIRATION DATE: 24-SEP-2023. 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

THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 9 YEARS AND 6 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT, REVISED THE 36/G FLAT PE HC LINER TO A 40/G FLAT PE HC LINER, AND REVISED 36MM BIOLOX DELTA HEAD M TO A 40MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.