InjuryKWJ
TOTAL ELBOW REPLACEMENT WITH FLEXI-HINGE
Received Sep 19, 2025
Report 3013450937-2025-00229 · MDR key 23097167
Device
Generic name
Total Elbow Replacement With Flexi-hinge
Manufacturer
Onkos SurgicalModel number
PIN 19132Lot number
PIN 19132
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. AN INVESTIGATION OF THE DEVICE HISTORY RECORD AND POST-MARKET SURVEILLANCE HISTORY WAS COMPLETED AND NOTHING WAS FOUND. IF ADDITIONAL INFORMATION IS OBTAINED OR IF THE DEVICE IS RETURNED, A SUPPLEMENTAL MDR WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED THAT A REBUSHING WAS REQUESTED FOR THE IN-SITU TOTAL ELBOW REPLACEMENT WITH FLEXI-HINGE (PIN 19132).