AMISTEM-P COLLARED

Description of Event or Problem

AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A PERI-PROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE 40MM BIOLOX L HEAD TO A 40MM BIOLOX XL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 22 JULY 2026 STEM: AMISTEM-P COLLARED 01.18.448 AMISTEM-P COLLARED LAT. SIZE 8 (K173794) LOT 2520684: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2024. EXPIRATION DATE: 05-MAY-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD. 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.