DOUBLE MOBILITY LINER

Description of Event or Problem

THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE DM LINER FROM THE DM CONVERTER LINER. THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE 28 MM BIOLOX DELTA HEAD L TO A COCR BALL HEAD 12/14 D 28 MM SIZE XL AND REVISED THE DOUBLE MOBILITY HC LINER D 28/DME TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD AN MPACT MH WITH DM CONVERTER ON (B)(6) 2026 IN A REVISION OF COMPETITOR DEVICES.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 24 JUNE 2026: BALL HEADS: MECTACER 01.29.203 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-L (K112115) LOT 2513372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2025. EXPIRATION DATE: 13-MAY-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 63 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.26.2850MHC DOUBLE MOBILITY HC LINER D 28/DME (K092265) LOT 2521259: 110 ITEMS MANUFACTURED AND RELEASED ON 06-OCT-2025. EXPIRATION DATE: 15-SEP-2030. 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: 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.