DOUBLE MOBILITY LINER

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 15 JULY 2026 LINER: MPACT DM 01.26.2850MHC DOUBLE MOBILITY HC LINER D 28/DME, (K092265). LOT 2523290: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-OCT-2025. EXPIRATION DATE: 2030-SEPT-22. 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. BALL HEADS: MECTACER 01.29.201 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-S, (K112115). LOT. 2534694: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2026. EXPIRATION DATE: 2031-JAN-14. 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

AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE DOUBLE MOBILITY HC LINER D 28/DME TO THE SAME SIZE LINER, AND REVISED THE 28MM BIOLOX DELTA HEAD S TO A 28MM BIOLOX OPTION HEAD WITH S OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.