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

Catalog Number	2103-1140
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Flaked (1246); Material Separation (1562); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Limb Pain (4836)
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified on september 30, 2025 that a 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 1.5 years postoperatively.
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.

• Brand Name: U2 TOTAL KNEE SYSTEM
• Common Device Name: No Match
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no.57,park ave 2,science park; hsinchu city, 30075, taiwan; hsinchu, 30075 ; TW 30075
• Manufacturer Contact: lois ho ; no. 57., park ave 2, science park; hsinchu city, 30075, taiwan; hsinchu, 30075
• MDR Report Key: 25038515
• Report Number: 9681642-2026-00022
• Device Sequence Number: 21435352
• Product Code: MBH
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: 2103-1140
• Device Lot Number: 22M626B
• 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: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2023
• 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
• Patient Weight: 110 KG