10MM MORSE TAPER LONG STEM
Received Mar 5, 2025 · Event occurred Jul 5, 2024
Report 3025141-2025-00095 · MDR key 21521844
Device
Generic name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Manufacturer
Acumed, LlcModel number
TR-SL10-SCatalog number
TR-SL10-S
Lot number
572476
Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE REPORTED 10MM MORSE TAPER LONG STEM WAS NOT RETURNED FOR EVALUATION. HOWEVER, MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND FOR THE 10MM MORSE TAPER LONG STEM (PART NUMBER TR-SL10-S, BATCH NUMBERS 572476). BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
AN "ARH SOLUTIONS 2 HEAD 26MM, LEFT" FAILURE WAS REPORTED BY DUKE UNIVERSITY HOSPITAL FOR A POST OPERATIVE LOOSE IMPLANT. THE REVISION 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 3025141-2025-00094 FOR THE "ARH SOLUTIONS 2 HEAD 26MM, LEFT" INVOLVED IN THIS EVENT.