MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 15 JULY 2026: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT. 2606597: 98 ITEMS MANUFACTURED AND RELEASED ON 07-APR-2026. EXPIRATION DATE: 2031-MAR-17. 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. MPACT 01.32.3644HCT FLAT PE HC LINER D 36/E (K103721) LOT. 2523239: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2025. EXPIRATION DATE: 2030-SEP-28. 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 HIP INSTABILITY AFTER 17 DAYS FROM PRIMARY. THE SURGEON REVISED THE FLAT LINER TO A HOODED LINER AND THE HEAD TO A SAME SIZE HEAD.