MAUDE Adverse Event Report: U2 TOTAL KNEE SYSTEM; No Match

Catalog Number	2103-1140
Medical Device Problem Codes	Flaked (1246); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on investigations of all currently available information, a correlation between the reported event and this medical device cannot be confirmed at this time, nor can a definitive root cause be identified.However, given that the use of this product cannot be entirely ruled out as a potential cause or contributing factor to the event, this report is submitted in accordance with relevant regulatory requirements.
Event or Problem Description
The patient reported persistent pain after having a tka surgery using the u2 total knee system, and x-ray imaging revealed femoral component loosening and metal beads shedding at one year post-surgery.A revision surgery was performed on (b)(6) 2025.

• Brand Name: U2 TOTAL KNEE SYSTEM
• Common Device Name: No Match
• Manufacturer Contact: lois ho ; no. 57, park ave 2., science park,; hsinchu city, 30075, taiwan; hsinchu, 30075
• MDR Report Key: 25038878
• Report Number: 9681642-2026-00020
• Device Sequence Number: 9921036
• Product Code: JWH
• UDI-Device Identifier: 04712602345392
• UDI-Public: 04712602345392
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 2103-1140
• Device Lot Number: 23K993C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown