AMISTEM H FEMORAL STEMS

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 18 APRIL 2026 STEM: AMISTEM H 01.18.132 AMISTEM-H STD. SIZE 2 (K093944) LOT 2503944: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEP-2013. EXPIRATION DATE: 31-JUL-2018. 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 12 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.