MECTACER BIOLOX OPTION HEADS

Additional Manufacturer Narrative

BATCH REVIEWS PERFORMED ON 25 JUNE 2026: BALL HEADS: MECTACER 01.29.230H MECTACER HEAD BIOLOX OPTION 12/14 D 28 (K131518) LOT 2517560: 20 ITEMS MANUFACTURED AND RELEASED ON 28-JUL-2025. EXPIRATION DATE: 09-JUL-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.241A MECTACER SLEEVE 12/14 SIZE M (K131518) LOT 2500723: 30 ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2025. EXPIRATION DATE: 15-JAN-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.26.2846MHC DOUBLE MOBILITY HC LINER D 28/DMC (K241767) LOT 2523288: 94 ITEMS MANUFACTURED AND RELEASED ON 17-NOV-2025. EXPIRATION DATE: 22-OCT-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 65 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 PRIMARY RIGHT HIP SURGERY ON (B)(6), 2020. ON (B)(6), 2025, THE PATIENT CAME IN WITH PAIN LOCATED IN THE PELVIC REGION AND THE CAUSE IS UNKNOWN. THE PATIENT BELIEVED THE PAIN WAS DUE TO SCREW PLACEMENT DURING PRIMARY SURGERY. THE SURGEON REMOVED THE 15MM AND 20MM SCREWS IMPLANTED DURING THE PRIMARY. THE SURGEON ALSO REVISED THE 36MM BIOLOX HEAD TO A 28MM BIOLOX HEAD, REVISED THE FLAT D 36 LINER TO A D 28 DOUBLE MOBILITY LINER, AND IMPLANTED A DM CONVERTER AND BIOLOX OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY (MDR 2025-01329). ON (B)(6), 2026, THE PATIENT HAD HIP INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE D 28/DMC LINER TO A SAME SIZE LINER, AND REVISED THE 28MM BIOLOX OPTION HEAD AND M SLEEVE TO A SAME SIZE HEAD AND SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.