MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION USTAR II KNEE SYSTEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	2115-3400/2215-3400/2315-3201
Medical Device Problem Codes	Unintended System Motion (1430); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After reviewing the production and inspection records of the affected product and its corresponding components, no relevant non-conformity issues were found regarding the dimensions and appearance.Based on the investigation and analysis results, the anomaly resulted from poor soft tissue function, which failed to stabilize the knee.This led to abnormal gait and varus/valgus movement, causing excessive gasket wear.
Event or Problem Description
A patient underwent tka surgery in (b)(6) 2024.One year postoperatively, the patient began experiencing noise during knee movement and joint instability; a revision surgery was performed on (b)(6) 2025.

• Brand Name: USTAR II KNEE SYSTEM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no.57,park ave 2,science park; hsinchu city, 30075, taiwan; hsinchu 30075
• Manufacturer Contact: lois ho ; no. 57, park ave 2., science park,; hsinchu city, 30075, taiwan
• MDR Report Key: 25038514
• Report Number: 9681642-2026-00019
• Device Sequence Number: 10411453
• Product Code: KRO
• UDI-Device Identifier: 04719872179429
• UDI-Public: 04719872179429
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K190100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/30/2026

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: 2115-3400/2215-3400/2315-3201
• Device Lot Number: 20L573A1 / 18H026C31 / 23J675A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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: Other
• Patient Age: 25 YR
• Patient Sex: Male