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

Catalog Number	2103-1640;2203-3740;2303-1741
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Limb Pain (4836)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is confirmed that the inspection results of the femoral component complied with design specifications with no relevant abnormal notes, and the necking bonding percentage of porous coating complied with the specification requirements.Based on our review of all currently available information, a correlation between the reported event and the device cannot be confirmed, nor can a definitive root cause be identified.A follow-up report will be provided upon receipt of further clinical information and investigation results.Products related to this event: 1.Femoral component, cruciate retaining, pf+, #4, right (product number: 2103-1640 / lot number: 24a439a), (udi: (b)(4)).2.Tibial baseplate, with 20 mm stem, pf+, #4 (product number: 2203-3740 / lot number: 24h804a), (udi: (b)(4)).3.E-xpe tibial insert, ultracongruent, #4, 9 mm thick (product number: 2303-1741 / lot number: 24m047bp), (udi: (b)(4)).
Event or Problem Description
A complaint case regarding the femoral component was received by the u.S.Subsidiary on (b)(6) 2026.A 59-year-old female patient underwent tka surgery using the u2 total knee system on (b)(6) 2025.The patient returned with continued pain, worsened pain, and stiffness.The x-ray showed several small radiopaque spots adjacent to the bone cut surface of the femoral component.The physician indicates that further evaluation of the patient's condition is needed to determine whether revision surgery is required.

• 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, hsinchu city 30075 ; TW 30075
• Manufacturer Contact: lois ho ; no. 57., park ave 2.; science park; hsinchu city, hsinchu city 30075 ; TW 30075
• MDR Report Key: 25631332
• Report Number: 9681642-2026-00027
• Device Sequence Number: 21170508
• Product Code: MBH
• UDI-Device Identifier: 04719872146254
• UDI-Public: 0104719872146254173404151024A439A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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: 2103-1640;2203-3740;2303-1741
• Device Lot Number: 24A439A;24H804A;24M047BP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 130 KG