VERSAFITCUP CC TRIO ACETABULAR SYSTEM

Description of Event or Problem

REVISION SURGERY DUE TO A LOOSE CUP AFTER ABOUT 5 YEARS AND 3 MONTHS. THE SURGEON REVISED THE VERSAFITCUP METALBACK CC TRIO D 48 MM TO A MPACT 3D METAL SHELL TWO HOLE D 52MM, REVISED THE FLAT PE HC LINER D 32/C TO A DOUBLE MOBILITY HC LINER D 28/DMC WITH DM CONVERTER, AND REVISED THE 32MM BIOLOX DELTA HEAD M TO A 28MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 09 JULY 2026 LOT 2006316: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2020. EXPIRATION DATE: 23-SEP-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP 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.