MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 1 JULY 2026: BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K112115) LOT 2600881: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-FEB-2026. EXPIRATION DATE: 19-JAN-2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER D 36/F (K103721) LOT 2528034: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2025. EXPIRATION DATE: 23-NOV-2030. 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

THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE HEAD AND LINER AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. AT ABOUT 20 DAYS FROM PRIMARY THE SURGEON REVISED THE 36MM BIOLOX DELTA HEAD S TO A 28MM BIOLOX OPTION HEAD WITH SLEEVE L, AND REVISED THE FLAT PE HC LINER D 36/F TO A DOUBLE MOBILITY HC LINER D 28/DMF WITH DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.