MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORP. U2 TOTAL KNEE SYSTEM

Catalog Number	2103-3230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Shock (2072); Chills (2191); Alteration in Body Temperature (4568)
Date of Event	03/25/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
1.All units from the associated lot have been distributed and implanted: 2103-3230 femoral component (b)(4) pcs), 2203-3020 tibial baseplate (b)(4) pcs), 2303-3021 tibial insert (b)(4) pcs), and 2403-1020 patella onset (b)(4) pcs).No similar complaints have been reported aside from this case.Therefore, this event is considered an isolated clinical case and 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 femoral component, posterior stabilized, #3, right (product number: 2103-3230 / lot number: 23c066b) (udi: (b)(4).(2) u2 total knee system tibial baseplate, cemented, #2 (product number: 2203-3020 / lot number: 22c807b) (udi: (b)(4).(3) u2 total knee system tibial insert, posterior stabilized, #2, 9mm thick (product number: 2303-3021 / lot number: 23a304c) (udi: (b)(4).(4) u2 total knee system patella, on set, small, 29mm dia.8mm thick (product number: 2403-1020 / lot number: 22g107f) (udi: (b)(4).
Event or Problem Description
On (b)(6) 2023, a patient with right knee disease underwent right total knee arthroplasty with implantation of a femoral component, tibial baseplate, tibial insert, and patellar component.The procedure was uneventful.Postoperatively, the patient developed fever, chills, and progressive shock, and was transferred to the icu.On (b)(6) 2023, the patient experienced cardiac arrest to multiple organ failure and expired.

• Brand Name: U2 TOTAL KNEE SYSTEM
• Common Device Name: U2 TOTAL KNEE SYSTEM
• Manufacturer (Section D): UNITED ORTHOPEDIC CORP.; 57, park ave. 2, science park,; hsinchu, 300 ; TW 300
• Manufacturer Contact: lois ho ; 57, park ave. 2, science park, hsinchu 300, taiwan; hsinchu, 300 ; TW 300
• MDR Report Key: 24837933
• Report Number: 9681642-2026-00004
• Device Sequence Number: 6027506
• Product Code: JWH
• UDI-Device Identifier: 04712602345682
• UDI-Public: 04712602345682
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 2103-3230
• Device Lot Number: 23C066B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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: Death
• Patient Age: 75 YR
• Patient Sex: Female