UNK
Received Dec 19, 2025 · Event occurred Sep 18, 2025
Report 1220246-2025-05727 · MDR key 23850863
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
- Failure of Implant
- Failure of Implant
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. CONSIDERING THAT THE IMPLANTATION SURGERY OCCURRED ON 05 SEP 2019 AND THE REPORTED EVENT OCCURRED IN 2025, THE FAILURE IS MORE LIKELY ASSOCIATED WITH THE PATIENT¿S ACTIVE LIFESTYLE AND PHYSICAL WORKLOAD. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THAT FAILURE WAS RECEIVED.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
ON (B)(6) 2025 IT WAS REPORTED VIA EMAIL BY THE ARTHREX CLINICAL RESEARCH TEAM THAT THE FOLLOWING INFORMATION WAS OBTAINED FROM A CLINICAL STUDY: PATIENT UNDERWENT KNEE MEDIAL UNICOMPARTMENTAL ARTHROPLASTY UTILIZING IBALANCE UKA ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF THE KNEE DUE TO FAILURE OF THE UKA ON (B)(6) 2025.