VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 03 JULY 2026: MPACT DM 01.26.2846MHC DOUBLE MOBILITY HC LINER D 28/DMC (K241767) LOT. 2338169: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2023. EXPIRATION DATE: 22-NOV-2028. 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. MPACT DM 01.32.3844CF DM CONVERTER E/DMC - TIN COATED (K211891) LOT. 2309715: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2023. EXPIRATION DATE: 23-OCT-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED FOR THE REPORTED DISLOCATION OF THE DOUBLE MOBILITY LINER FROM THE DM CONVERTER LINER. NO TRAUMA WAS INDICATED, AND THE AVAILABLE INFORMATION DOES NOT ALLOW CONFIRMATION OF A SPECIFIC CLINICAL, APPLICATION-RELATED, OR DEVICE-RELATED CAUSE. THE DEVICE HISTORY RECORD REVIEWS FOR THE INVOLVED LOTS DID NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE, AND NO SIMILAR EVENTS WERE IDENTIFIED FOR THE REVIEWED SOLD ITEMS OF THE SAME LOTS.

Description of Event or Problem

REVISION SURGERY DUE TO A DISLOCATION OF THE DM LINER FROM THE DM CONVERTER LINER AFTER ABOUT 1 MONTH FROM PRIMARY. THE SURGEON REVISED THE MEDACTA CUP, LINER, DM CONVERTER AND HEAD TO COMPETITOR DEVICES.