9.0MM X 2.0MM STEM

Additional Manufacturer Narrative

THE REPORTED 9.0MM X 2.0MM STEM WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE 9.0MM X 2.0MM STEM (PART NUMBER TR-S0902-S) BATCH/LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

AN "ARH SOLUTIONS 2 HEAD 20MM, LEFT" FAILURE WAS REPORTED BY DUKE RALEIGH HOSPITAL FOR A POST OPERATIVE LOOSE IMPLANT. THE INDEX SURGERY WAS PERFORMED ON (B)(6) 2023. 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 3025141-2025-00088 FOR THE "ARH SOLUTIONS 2 HEAD 20MM, LEFT" INVOLVED IN THIS EVENT.

Description of Event or Problem

A LOOSE IMPLANT, RELATED TO A PROCEDURE THAT TOOK PLACE ON (B)(6) 2023 AT (B)(6) HOSPITAL REPORTED. HOWEVER, IT IS UNCLEAR WHICH OF TWO DEVICES WERE IMPLANTED, A 9.0MM X 2.0MM STEM OR A 9.0MM X 0.0MM STEM. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2025-00088.

Additional Manufacturer Narrative

THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE PART NUMBER AND BATCH/LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.