UNK
Received Dec 18, 2025 · Event occurred Jul 10, 2025
Report 1220246-2025-05699 · MDR key 23842820
Device
Generic name
Knee Prosthesis Pat/fem Cement
Manufacturer
Arthrex, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Pain
- Pain
Narrative
Description of Event or Problem
ON 24-NOV-2025 IT WAS REPORTED BY THE ARTHREX CLINICAL RESEARCH TEAM VIA EMAIL THAT WHILE REVIEWING A CLINICAL STUDY, IT WAS NOTED A PATIENT WHO HAS HAD A IMBALANCE UKA HAS LEFT KNEE PAIN RELATED TO PROGRESSIVE OSTEOARTHRITIS. THE PATIENT FAILED CONSERVATIVE TREATMENT. ON (B)(6) 2025 X-RAYS SHOW NO EVIDENCE OF HARDWARE FAILURE OR LOOSENING AND THE MEDIAL UKA IS REPORTED TO BE IN PLACE. IT WAS REPORTED ON (B)(6) 2025 A REVISION WAS PERFORMED FOR A FAILED UKA.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT, WHICH WAS CAUSING LEFT KNEE PAIN RELATED TO PROGRESSIVE OSTEOARTHRITIS.