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

Catalog Number	21K187A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint product will be returned to our company for investigation.And the production history will also be confirmed.The investigation of this event is in process now.If information is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
A complaint case regarding the femoral component was received by the france branch on 2026/04/21.A 65-year-old female patient underwent tka surgery using the u2 total knee system on (b)(6) 2022, and the patient experienced intense pain after surgery.The x-ray showed the femoral component loosening.A revision surgery was performed on (b)(6) 2026.

• 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 ; TW 30075
• Manufacturer Contact: lois ho ; no. 57., park ave 2; science park; hsinchu city 30075 ; TW 30075
• MDR Report Key: 25238428
• Report Number: 9681642-2026-00024
• Device Sequence Number: 10500707
• Product Code: MBH
• UDI-Device Identifier: 04712602345446
• UDI-Public: 01047126023454461727030210
• 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: 2022
• Device Explanted Year: 2026
• 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): 05/20/2026

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: 21K187A
• Device Lot Number: 2103-1230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/21/2026
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 137 KG