BIPOLAR HEADS

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 07 JUL 2026 LOT 2417181: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2024. EXPIRATION DATE: 2029-OCT-29. 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

REVISION SURGERY DUE TO JOINT LUXATION BETWEEN BIPOLAR HEAD AND ACETABULUM AFTER ABOUT 2 MONTHS FROM PRIMARY. THE SURGEON REVISED THE HEMI HIP TO A TOTAL HIP.