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

Catalog Number	2103-1230
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint product will be returned for investigation.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.As of the reporting date, the complaint product has not yet been obtained.The final report will be submitted if the complaint product is received and further investigation results are available.
Event or Problem Description
A complaint case regarding the femoral component was received by the french branch on 2026/05/29.A 76-year-old female patient underwent tka surgery using the u2 total knee system on (b)(6) 2023.The patient was admitted for surgical treatment of a tibial fracture resulting from a fall.However, as a precautionary measure, the assessment revealed a lack of osseointegration of the femoral component.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, 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: 25631336
• Report Number: 9681642-2026-00028
• Device Sequence Number: 9353524
• Product Code: MBH
• UDI-Device Identifier: 04712602345446
• UDI-Public: 0104712602345446172710141022G151B
• 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: 2023
• 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): 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: 2103-1230
• Device Lot Number: 22G151B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/25/2026
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 90 KG