MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 01 JUL 2026 LOT 151157: 93 ITEMS MANUFACTURED AND RELEASED ON 22-APR-2015. EXPIRATION DATE: 2020-MAR-31. 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. 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

AT10 YEARS 5 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING HIP PAIN ALONG WITH FLEXION DIFFICULTY GREATER THAN 90 DEGREES AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A DEBRIDEMENT, WASHOUT, AND REVISED THE 32MM BIOLOX DELTA HEAD S TO A 32MM BIOLOX DELTA HEAD M. THE SURGERY WAS COMPLETED SUCCESSFULLY.