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

Catalog Number	2315-3211
Medical Device Problem Codes	Fracture (1260); Failure to Align (2522); Mechanics Altered (2984)
Health Effect - Clinical Code	Hyperextension (4523)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on investigations of all currently available information, a correlation between the reported event and this medical device cannot be confirmed at this time, nor can a definitive root cause be identified.However, given that the use of this product cannot be entirely ruled out as a potential cause or contributing factor to the event, this report is submitted in accordance with relevant regulatory requirements.
Event or Problem Description
The manufacturer was notified on (b)(6) 2024 that a patient had undergone knee arthroplasty two years earlier.The patient later returned for follow-up due to pain, and x-ray images showed fractures of the screw and the metal portion of the insert.A revision surgery was subsequently performed.

• 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 ave2,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, 30075
• MDR Report Key: 25038512
• Report Number: 9681642-2026-00018
• Device Sequence Number: 10411452
• Product Code: KRO
• UDI-Device Identifier: 04711605580304
• UDI-Public: 04711605580304
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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: 2315-3211
• Device Lot Number: 21J571A
• 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: 10/12/2021
• 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: Unknown