ARH SOLUTIONS 2 HEAD 20MM, RIGHT
Received Mar 5, 2025
Report 3025141-2025-00082 · MDR key 21521832
Device
Generic name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Manufacturer
Acumed, LlcModel number
5001-0520R-SCatalog number
5001-0520R-S
Lot number
598999
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 ARH SOLUTIONS 2 HEAD 20MM, RIGHT WAS NOT RETURNED FOR EVALUATION. HOWEVER, MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND FOR THE ARH SOLUTIONS 2 HEAD 20MM, RIGHT (PART NUMBER 5001-0520R-S, BATCH NUMBERS 598999). BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
AN "ARH SOLUTIONS 2 HEAD 20MM, RIGHT" FAILURE WAS REPORTED BY (B)(6) 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 3025141-2025-00083 FOR THE "8.0MM X 0.0MM STEM" INVOLVED IN THIS EVENT.