AMIS TABLE

Additional Manufacturer Narrative

CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT DURING PRIMARY PARTIAL HIP ARTHROPLASTY ON AN ELDERLY PATIENT WITH VERY POOR BONE QUALITY, THE MANOUEVERS TO EXPOSE THE HIP LEAD TO FRACTURE OF THE TIBIA AND FIBULA. THE REASON WAS EXCESSIVE FORCE APPLIED COMPARED TO THE BONE STRENGTH; NO RESPONSIBILITY FOR ANY OF THE DEVICES INOLVED. BATCH REVIEW PERFORMED ON 14 JULY 2026 LOT 1112845AA-(B)(6): (B)(4) ITEM MANUFACTURED AND RELEASED ON 26-MAY-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. ROOT CAUSE:IT MOST LIKELY THAT THE SPECIFIC PATIENT CONDITIONS AND UNIQUE SURGICAL FACTORS RESULTED IN THE ISSUE REPORTED. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem

ON (B)(6) 2026, DURING A BIPOLAR HIP SURGERY, AFTER EXPOSURE AND REMOVAL OF THE FEMORAL HEAD, THE LOWER LEG WAS EXTERNALLY ROTATED TO 130° FOR STEM MANIPULATION, AND THE LEG POSITIONER WAS LOWERED TO ITS LOWEST POSITION. AS AN ADEQUATE SURGICAL VIEW FOR STEM MANIPULATION COULD NOT BE OBTAINED, THE LEG POSITIONER WAS RAISED AGAIN TO ITS HIGHEST POSITION, AND THE LIMB WAS EXTERNALLY ROTATED AGAIN TO 130°. ADDITIONAL INTRA-ARTICULAR RELEASE WAS PERFORMED, ALLOWING EXTERNAL ROTATION UP TO 150°. WHEN THE LEG POSITIONER WAS LOWERED AGAIN FROM THE HIGHEST POSITION, AN ABNORMAL SOUND WAS HEARD FROM THE TIBIA AROUND THE SECOND TO THIRD LEVEL OF THE LEG POSITIONER. IMAGING CONFIRMED FRACTURES OF THE TIBIA AND FIBULA. SINCE NO PREPARATION HAD BEEN MADE TO MANAGE TIBIA AND FIBULA FRACTURES, THE HIP PROCEDURE WAS COMPLETED AND AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2026 TO FIX THE FRACTURE. PATIENT WAS VERY OLD (B)(6) YEARS OLD) AND BONE QUALITY WAS VERY WEAK.