MPACT ACETABULAR SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 09 JULY 2026 CUP: MPACT 01.32.160DH ACETABULAR SHELL D 60 TWO-HOLE (K132879) LOT. 2531438: 32 ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2024. EXPIRATION DATE: 2029-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE:ASEPTIC LOOSENING IS POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

Description of Event or Problem

AT ABOUT 1 YEAR 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE CUP AS THE RESULT OF MINOR BONE GROWTH. THE SURGEON REVISED THE ACETABULAR SHELL D 60 TWO-HOLE TO A MPACT 3D METAL SHELL MULTI HOLE D 66MM AND REVISED THE FLAT PE HC LINER D 40/G TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.