DOUBLE MOBILITY LINER

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 06 JUL 2026 LINER: MPACT DM 01.26.2852MHC DOUBLE MOBILITY HC LINER D 28/DMF (K092265) LOT 2601010: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2026. EXPIRATION DATE: 2031-FEB-10. 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 01.29.230H MECTACER HEAD BIOLOX OPTION 12/14 D 28 (K131518) LOT. 2519245: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEPT-2025. EXPIRATION DATE: 2030-JUL-17. 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 01.29.243A MECTACER SLEEVE 12/14 SIZE XL (K131518) LOT. 2515762: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2025. EXPIRATION DATE: 2030-JUN-11. 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 ONE MONTH 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/DMF, 28MM BIOLOX OPTION HEAD, AND BIOLOX OPTION SLEEVE XL TO A SAME SIZE LINER, HEAD, AND SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.