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

Catalog Number	2103-3260;2203-3040;2303-3041
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Limb Pain (4836); Medical device site infection (4845)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An adverse event regarding the femoral component was received on (b)(6) 2026.A 70-year-old male patient underwent rt.Tka surgery using the u2 total knee system on (b)(6) 2025.The procedure was uneventful, and the patient was discharged in stable condition with regular follow-up.The patient has experienced pain in the right knee joint since (b)(6) 2026.The test results of the joint aspirate indicated streptococcus anginosus infection, and imaging studies revealed a radiolucent line around the implant.Due to septic loosening of the implant, debridement and revision surgery were performed on (b)(6) 2026, followed by antimicrobial therapy.
Additional Manufacturer Narrative
The products suspected in the reported adverse event were not returned for investigation.A review of the manufacturing records for the reported femoral component, tibial baseplate, tibial insert, and products from the same lot confirmed that the final product dimensions and appearance were all in compliance with the design specifications, with no relevant abnormal findings documented.Accordingly, manufacturing quality defects or design-related anomalies are not considered to have contributed to the reported event.In addition, the patient had high-risk factors for infection, including advanced age and a history of diabetes mellitus.Accordingly, the physician determined that this adverse event was attributable to the patient's compromised immune condition.This case is considered an isolated 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.We are submitting this report as our product cannot be excluded as a potential contributory factor to the reported issue.The product associated with this case: 1.Femoral component, posterior stabilized, #6, right (product number: 2103-3260 / lot number: 24k292a), (udi: (b)(4).2.Tibial baseplate, cemented, #4 (product number: 2203-3040 / lot number: 24l485b)(udi: (b)(4).3.Tibial insert, posterior stabilized, #4, 9mm thick (product number: 2303-3041 / lot number: 24j457ae),(udi: (b)(4).

• 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: 25313004
• Report Number: 9681642-2026-00026
• Device Sequence Number: 16088252
• Product Code: JWH
• UDI-Device Identifier: 04712602345712
• UDI-Public: 0104712602345712173412021024K292A
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: 2103-3260;2203-3040;2303-3041
• Device Lot Number: 24K292A;24L485B;24J457AE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/28/2026
• 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: 70 YR
• Patient Sex: Male