AMISTEM-P COLLARED

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 02 JULY 2026 AMISTEM-P COLLARED 01.18.441 AMISTEM-P COLLARED LAT. SIZE 1 (K173794) LOT 2238600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 FEBRUARY 2023. EXPIRATION DATE: 10 JANUARY 2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. MPACT 01.32.146DHT ACETABULAR SHELL D 46 TWO-HOLES T (K230011) LOT 2418545: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 NOVEMBER 2024. EXPIRATION DATE: 22 OCTOBER 2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE, THE REVISION SURGERY WAS PERFORMED DUE TO A REPORTED TITANIUM ALLERGY, WITH NO ALLEGED DEVICE DEFICIENCY INVOLVED. THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

Description of Event or Problem

REVISION SURGERY DUE TO TITANIUM ALLERGY AFTER ABOUT 9 MONTHS AFTER PRIMARY. THE SURGEON REMOVED ALL EXISTING IMPLANTS, CEMENTED A HOODED PE HC LINER D 36/E AND QUADRA-P CEMENTED LAT. SIZE 1 AND REVISED THE 32MM BIOLOX DELTA HEAD S TO A 36MM BIOLOX DELTA HEAD M. THE PATIENT HAD A FRACTURE SO THE TITANIUM CABLES WERE REPLACED WITH MBRACE CABLES. THE SURGERY WAS COMPLETED SUCCESSFULLY.