UNK
Received Dec 19, 2025 · Event occurred Apr 12, 2022
Report 1220246-2025-05730 · MDR key 23851437
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
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD DATA, ARTHREX CONCLUDED THE MOST LIKELY CAUSE OF THE REPORTED FAILURE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A PATIENT-SPECIFIC EVENT. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THAT FAILURE WAS RECEIVED.
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, A PATIENT HAD SURGERY ON (B)(6) 2018 UTILIZING THE IBALANCE UKA, AND DUE TO PAIN, THE PATIENT HAD A REVISION IN WHICH THE DEVICES WERE EXPLANTED IN 2022.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.