MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Description of Event or Problem

REVISION SURGERY DUE TO JOINT LUXATION AFTER ABOUT 3 MONTHS FROM PRIMARY. THE SURGEON REVISED THE 36 MM BIOLOX DELTA HEAD S TO A 28 MM BIOLOX OPTION HEAD WITH SLEEVE L AND REVISED THE FLAT PE HC LINER D 36/E TO A DOUBLE MOBILITY HC LINER D 28/DMC ALONG WITH A DM CONVERTER.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 09 JULY 2026: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K112115) LOT. 2532288: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-DEC-2025. EXPIRATION DATE: 2030-DEC-11. 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. MPACT 01.32.3644HCT FLAT PE HC LINER D 36/E (K103721) LOT. 2528030: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JAN-2026. EXPIRATION DATE: 2030-NOV-25. 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.