AMISTEM H FEMORAL STEMS

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 12 JUNE 2026 STEM: AMISTEM H 01.18.135 AMISTEM-H STD. SIZE 5 (K093944) LOT 146961: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2015. EXPIRATION DATE: 31-DEC-2019. 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:ASEPTIC LOOSENING IS POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

Description of Event or Problem

AT ABOUT 11 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE 36/F MPACT FLAT LINER TO A FACE CHANGING 10° PE HC LINER D 40/F. THE SURGERY WAS COMPLETED SUCCESSFULLY.