AMISTEM H FEMORAL STEMS

Additional Manufacturer Narrative

CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 8 YEARS AFTER PRIMARY CEMENTLESS THA THE PATIENT COMPLAINS ABOUT PAIN AND THE RADIOGRAPH SHOWS A PROXIMALLY LOOSE STEM. THERE IS NO INFORMATION AVAILABLE THAT CAN LEAD TO A POSSIBLE CAUSE FOR THIS ADVERSE EVENT. LATE STEM LOOSENING IS A KNOWN COMPLICATION AFTER CEMENTLESS THA AND MAY HAVE A MULTIFACTORIAL ETIOLOGY. BASED ON THE INFORMATION AT HAND, THE ROOT CAUSE REMAINS UNDETERMINED, AND THERE ARE NO ELEMENTS TO SUGGEST A DEFECTIVE OR MALFUNCTIONING DEVICE. BATCH REVIEW PERFORMED ON 14 JULY 2026 01.18.098 AMISTEM-H STD. SIZE00 (K121011) LOT. 165557: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 DECEMBER 2016. EXPIRATION DATE: 06 DECEMBER 2021. 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 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 AFTER 8 YEARS AND 1 MONTH DUE TO STEM LOOSENING. THE STEM WAS REVISED TO A COMPETITOR`S ONE.