AMISTEM-P COLLARED

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 11 JUNE 2026 STEM: AMISTEM-P COLLARED 01.18.440 AMISTEM-P COLLARED LAT. SIZE 0 (K173794) LOT 2520365: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2026. EXPIRATION DATE: 08-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: BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. THE ABSENCE OF X-RAYS AND FURTHER CLINICAL DETAILS DOES NOT ALLOW A MORE PRECISE CONCLUSION. THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE, AND THERE IS NO INDICATION THAT A DEVICE-RELATED ISSUE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem

AT ABOUT 1 WEEK FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A FRACTURED FEMUR AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA.THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR DEVICES AND REPLACED THE DOUBLE MOBILITY LINER WITH A LINER OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.