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

Catalog Number	2303-3031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.On (b)(6) 2025, the patient was admitted due to postoperative wound infection of the knee and underwent debridement, removal of the left knee prosthesis, and revision surgery, followed by anti-infective treatment.The affected device was not returned.Review of the production records showed no abnormalities, and no similar complaints have been reported for the same lot.The hospital assessed the infection as related to the patient's compromised immune condition.This case is considered an individual clinical event, not related to product quality.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.2.The product associated with this case: (1) u2 total knee system, tibial insert, posterior stabilized, #3, 9mm thick (product number: 2303-3031 / lot number: 23j601ag) (udi: (b)(4)).(2) u2 total knee system, tibial baseplate, cemented, #3 (product number: 2203-3030 / lot number: 23g517c) (udi: (b)(4)).(3) u2 total knee system, patella, on set, small, 29mm dia.8mm thick (product number: 2403-1020 / lot number: 23a741f) (udi: (b)(4)).(4) u2 total knee system femoral component, posterior stabilized, #4, left (product number: 2103-3140 / lot number: 23m162b) (udi: (b)(4)).
Event or Problem Description
On (b)(6) 2024, the patient underwent left total knee arthroplasty with implantation of a femoral component, tibial baseplate, tibial insert, and patellar component.The procedure was uneventful, and the patient was discharged in improved condition with routine follow-up.Postoperatively, the patient had acceptable range of motion but experienced intermittent pain.Joint aspiration confirmed streptococcus agalactiae infection, and imaging showed a radiolucent line around the prosthesis, consistent with prosthetic joint infection and loosening.On (b)(6) 2025, the patient was admitted due to postoperative wound infection and underwent debridement and revision surgery, followed by anti-infective treatment.

• Brand Name: U2 TOTAL KNEE SYSTEM
• Common Device Name: No Match
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no57, park ave2, 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: 24841649
• Report Number: 9681642-2026-00005
• Device Sequence Number: 9827863
• Product Code: JWH
• UDI-Device Identifier: 04712602348102
• UDI-Public: 04712602348102
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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: 2303-3031
• Device Lot Number: 23J601AG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female