MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 01 JUL 2026 BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT 1910893: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30/APR/2020. EXPIRATION DATE: 16/APR/2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MPACT 01.32.3648HC4 OFFSET 4MM PE HC LINER D 36/F (K183582) LOT. 1810836: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11/MAR/2019. EXPIRATION DATE: 21/FEB/2024. 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: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

Description of Event or Problem

AT 5 YEARS 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISLOCATION OF THE HEAD AND LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE 36MM BIOLOX HEAD M A 28MM BIOLOX OPTION HEAD WITH SLEEVE M AND REVISED THE OFFSET 4MM PE HC LINER D 36/F TO A CONSTRAINED PE LINER D 28/F. THE SURGERY WAS COMPLETED SUCCESSFULLY.