MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 09 JUNE 2026: MECTACER 01.29.212 MECTACER HEAD BIOLOX DELTA DIA.40 12/14-S (K112115) LOT. 2516326: (B)(4) MANUFACTURED AND RELEASED ON 09-JUL-2025. EXPIRATION DATE: 2030-JUN-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MPACT 01.32.4048HCT FLAT PE HC LINER D 40/F (K103721) LOT. 2514659: (B)(4) MANUFACTURED AND RELEASED ON 25-JUL-2025. EXPIRATION DATE: 2030-JUL-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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

REVISION SURGERY DUE TO JOINT LUXATION AFTER ABOUT 8 MONTHS FROM PRIMARY SURGERY. THE SURGEON REVISED THE 40MM BIOLOX DELTA HEAD S TO A 28MM BIOLOX DELTA HEAD M AND REVISED THE FLAT PE HC LINER D 40/F TO A CONSTRAINED 10° PE LINER D 28/F. THE SURGERY WAS COMPLETED SUCCESSFULLY.