MPACT ACETABULAR SYSTEM

Additional Manufacturer Narrative

BATCH REVIEWS PERFORMED ON 20 APRIL 2026: CUP: MPACT 01.32.146DHT ACETABULAR SHELL Ø46 TWO-HOLES T (K250450) LOT 2338374: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2024. EXPIRATION DATE: 25-FEB-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C (K103721) LOT 2339884: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2023. EXPIRATION DATE: 05-NOV-2028. EXPIRATION DATE: 05-NOV-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 90 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.205 MECTACER HEAD BIOLOX DELTA DIA.32 12/14-M (K112115) LOT 2404439: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2024. EXPIRATION DATE: 17-FEB-2029. 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. HIP INSTABILITY MAY OCCUR DUE TO NUMEROUS APPLICATION-SPECIFIC FACTORS, HOWEVER NO PARTICULAR ISSUES WERE REPORTED IN THIS CASE. ALTHOUGH A ROOT CAUSE COULD NOT BE IDENTIFIED, THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY. THIS PATIENT HAD A FOLLOWING REVISION SUGERY THAT WILL BE REPORTED.

Description of Event or Problem

THE PATIENT HAD HIP INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA OR BONE QUALITY ISSUES REPORTED. AT ABOUT 1 YEAR AND 9 MONTHS POST PRIMAR THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER. THE SURGEON ALSO REVISED THE 32 MM BIOLOX HEAD M TO A 36 MM BIOLOX HEAD S. THE SURGERY WAS COMPLETED SUCCESSFULLY.