PROFEMUR® ROUGHENED DISTAL STEM, TAPERED

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

Description of Event or Problem

ALLEGEDLY, THE PATIENT PRESENTED TO CONSULTATION ON (B)(6) 2025, AS A CONSULTATION FROM THE (B)(6) HOSPITAL ((B)(6)) DUE TO AN IMPLANT FRACTURE. HE REPORTED THAT A WEEK AGO, WHILE DESCENDING STAIRS, HE SUDDENLY FELT A NOISE IN HIS LEFT HIP. HE WAS ABLE TO WALK A FEW STEPS, BUT AFTERWARD, WALKING WAS NO LONGER POSSIBLE DUE TO THE PAIN SYMPTOMS. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2025.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE IMPLANT HAS FRACTURED. THE TIME OF IMPLANTATION IS UNKNOWN, BUT THE IMPLANT COMPLETED THE MANUFACTURING PROCESS IN 2017. THE EXPLANTED COMPLAINT DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION, NOR HAVE ANY IMAGES OR RADIOGRAPHS BEEN RECEIVED TO CONFIRM THE FRACTURE. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT MANUFACTURING LOT INDICATES THAT THIS PART MET ALL ESTABLISHED ACCEPTANCE CRITERIA THROUGHOUT MANUFACTURING PROCESSES. FURTHERMORE, THIS REPORT IS THE FIRST AND ONLY COMPLAINT INVOLVING THE SUBJECT DEVICE. MPO DOES NOT HAVE ANY INFORMATION REGARDING THE NATURE OF THE FRACTURE NOR ANY DETAILS REGARDING THE OTHER PRODUCTS THAT WERE IMPLANTED WITH THE SUBJECT DEVICE. AS CAPTURED WITHIN MICROPORT'S CURRENT HIP SYSTEMS PACKAGE INSERT (150803-9), "FATIGUE FRACTURE OF THE PROSTHETIC COMPONENT CAN OCCUR AS A RESULT OF TRAUMA, STRENUOUS ACTIVITY, IMPROPER ALIGNMENT, INCOMPLETE IMPLANT SEATING, DURATION OF SERVICE, LOSS OF FIXATION, NON-UNION, OR EXCESSIVE WEIGHT." WITHOUT ADDITIONAL DETAILS, MPO IS UNABLE TO PROVIDE CONCLUSIONS REGARDING THIS INCIDENT. THERE WERE NO TRENDS IDENTIFIED FOR THIS MODEL OR PRODUCT FAMILY AT THE TIME OF THIS EVENT. MPO WILL CONTINUE TO MONITOR THIS FAILURE TYPE THROUGH COMPLAINT TRACKING.