ARH SOLUTIONS 2 HEAD 22MM, LEFT
Received Mar 5, 2025 · Event occurred Apr 11, 2023
Report 3025141-2025-00092 · MDR key 21521839
Device
Generic name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Manufacturer
Acumed, LlcModel number
5001-0522L-SCatalog number
5001-0522L-S
Lot number
590256
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
Description of Event or Problem
AN "ARH SOLUTIONS 2 HEAD 22MM, LEFT" FAILURE WAS REPORTED BY (B)(6) 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 3025141-2025-00093 FOR THE "8MM MORSE TAPER LONG STEM" INVOLVED IN THIS EVENT.
Additional Manufacturer Narrative
THE REPORTED ARH SOLUTIONS 2 HEAD 22MM, LEFT WAS NOT RETURNED FOR EVALUATION. HOWEVER, MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND FOR THE ARH SOLUTIONS 2 HEAD 22MM, LEFT (PART NUMBER 5001-0522L-S, BATCH NUMBERS 590256). BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.
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.