MPACT ACETABULAR SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 19 JUN 2026 LOT 2432660: 100 ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2025. EXPIRATION DATE: 2030-JAN-27. 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: 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 SURGERY WITH COMPETITOR IMPLANTS. ON (B)(6), 2025, THE PATIENT WAS REVISED TO A MEDACTA ACETABULAR SHELL D 52 MULTI-HOLE AND FLAT PE HC LINER D 36/E. PRESENTLY, ON (B)(6), 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLAT PE HC LINER D 36/E TO A DOUBLE MOBILITY HC LINER D 28/DMC WITH DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.