8.0MM X 0.0MM STEM

Description of Event or Problem

AN "ARH SOLUTIONS 2 HEAD 20MM, RIGHT" FAILURE WAS REPORTED BY DUKE REGIONAL HOSPITAL FOR A POST OPERATIVE LOOSE IMPLANT. THE INDEX SURGERY WAS PERFORMED ON (B)(6) 2024. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE. IF/WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2025-00082 FOR THE "ARH SOLUTIONS 2 HEAD 20MM, RIGHT" INVOLVED IN THIS EVENT.

Additional Manufacturer Narrative

THE REPORTED 8.0MM X 0.0MM STEM WAS NOT RETURNED FOR EVALUATION. HOWEVER, MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND FOR THE 8.0MM X 0.0MM STEM (PART NUMBER TR-S0800-S, BATCH NUMBERS 599299). BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.