MPACT ACETABULAR SYSTEM

Description of Event or Problem

AFTER IMPLANTATION OF THE 52 MM CUP, ONE SCREW WAS USED FOR FIXATION. A E36 MM FLAT LINER(LOT2534778)WAS THEN INSERTED AND IMPACTED BUT FAILED TO ENGAGE. POTENTIAL CAUSES, INCLUDING OSTEOPHYTES, SOFT TISSUE INTERPOSITION, AND SCREW HEAD PROMINENCE, WERE CHECKED, AND THE LINER WAS REINSERTED WITHOUT SUCCESS. A SECOND LINER (LOT2601041)OF THE SAME SIZE ALSO FAILED TO ENGAGE. CONSEQUENTLY, THE 52 MM CUP WAS REMOVED AND REPLACED WITH A 54 MM CUP, INTO WHICH THE E36 MM FLAT LINER(LOT2601041)WAS SUCCESSFULLY INSERTED AND ENGAGED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE ISSUE RESULTED IN AN APPROXIMATELY 1-HOUR DELAY, WITH A TOTAL SURGICAL TIME OF ABOUT 2 HOURS. PATIENT`S BONE QUALITY REPORTED TO BE NORMAL. NO ADDITIONAL REAMING NECESSARY TO IMPLANT THE BIGGER CUP.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON (b)(6) 2026 LINER: MPACT 01.32.3644HCT FLAT PE HC LINER D 36/E (K103721) LOT 2534778: 120 ITEMS MANUFACTURED AND RELEASED ON (b)(6) 2026. EXPIRATION DATE: 2031-FEB-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 65 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CUP: MPACT 3D METAL 01.38.052DH MPACT 3D METAL SHELL TWO HOLE D 52MM (K171966) LOT 2608810: 69 ITEMS MANUFACTURED AND RELEASED ON (b)(6) 2026. EXPIRATION DATE: 2031-APR-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 25 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER D 36/E (K103721) LOT 2601041: 120 ITEMS MANUFACTURED AND RELEASED ON 02-MAR-2026. EXPIRATION DATE: 2031-FEB-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 47 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.