DOUBLE MOBILITY LINER

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 17 JULY 2026 MPACT DM 01.26.2858MHC DOUBLE MOBILITY HC LINER D 28/DMI (K092265) LOT: 2506499: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2025. EXPIRATION DATE: 05-MAY-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. MECTACER 01.29.202 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M (K112115) LOT: 2604563: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2026. EXPIRATION DATE: 19-FEB-2031. 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: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

Description of Event or Problem

REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE DM LINER AND HEAD.