8MM MORSE TAPER LONG STEM

Additional Manufacturer Narrative

THE REPORTED 8MM MORSE TAPER LONG STEM WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE 8MM MORSE TAPER LONG STEM (PART NUMBER TR-SL08-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 22MM, LEFT" FAILURE WAS REPORTED BY DUKE RALEIGH HOSPITAL FOR A POST OPERATIVE LOOSE IMPLANT. THE REVISION 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 3025141-2025-00092 FOR THE "ARH SOLUTIONS 2 HEAD 22MM, LEFT" INVOLVED IN THIS EVENT.

Description of Event or Problem

AN ARH 2 REVISION SURGERY REPORTED TAKING PLACE ON (B)(6) 2023 AT (B)(6) HOSPITAL.

Description of Event or Problem

AN ARH 2 REVISION SURGERY REPORTED TAKING PLACE ON (B)(6) 2024 AT (B)(6) HOSPITAL.

Additional Manufacturer Narrative

CORRECTION: DATE OF THE SURGERY IS (B)(6) 2024.

Additional Manufacturer Narrative

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

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 FOUR MORSE TAPER LONG STEMS PROVIDED ARE IMPLANTED. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2025-00092.