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

Catalog Number	2115-3310
Medical Device Problem Codes	Break (1069); Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Hyperextension (4523)
Date of Event	02/15/2024
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 analysis results, this event may be caused by the patient's knee anterior tilting movement.The distal femoral component hyperextension stop mechanism might be affected and lead to the adaptor fracture.
Event or Problem Description
A patient underwent knee joint replacement surgery on (b)(6) 2022.Two years postoperatively, the patient sought medical consultation due to pain, and a revision surgery was subsequently performed on (b)(6), 2024.The femoral component was found to be fractured and severely worn.

• 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 city, 30075 ; TW 30075
• Manufacturer Contact: lois ho ; no. 57, park ave 2, science park,; hsinchu city 30075, taiwan; hsinchu city, 30075
• MDR Report Key: 25038508
• Report Number: 9681642-2026-00015
• Device Sequence Number: 18744714
• Product Code: KRO
• UDI-Device Identifier: 04719872179436
• UDI-Public: 04719872179436
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K190100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Device Catalogue Number: 2115-3310
• Device Lot Number: 21H493A
• 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: 09/20/2021
• 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 Sex: Male
• Patient Race: Asian