AMISTEM H COLLARED FEMORAL STEMS

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 09 JULY 2026 LOT: 173444: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 OCT 2017. EXPIRATION DATE: 18 OCT 2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP 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.

Description of Event or Problem

REVISION SURGERY DUE TO STEM LOOSENING AFTER ABOUT 7 YEARS AND 6 MONTHS FROM PRIMARY. THE SURGEON REVISED THE AMISTEM H COLLARED STANDARD SIZE 4 TO A MONOBLOCK STEM D 13MM L 190MM STD, REVISED THE 36MM BIOLOX DELTA HEAD M TO A 40MM BIOLOX OPTION HEAD WITH SLEEVE, AND REVISED THE HOODED PE HC LINER D 36/F TO A FLAT PE HC LINER D 40/F AT HIS DISCRETION. XRAYS ARE UNAVAILABLE.