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

Catalog Number	2115-3410 / 2315-3241
Medical Device Problem Codes	Break (1069); Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Hyperextension (4523)
Date of Event	06/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After reviewing the production and inspection records of the affected product, no relevant non-conformity issues were found regarding the dimensions and appearance.It is found that the patient has experienced hyperextension that exceeds the design limits of knee joint range of motion; a bmi of 36 which may also generate extra moments on the implant in a hyperextended state.These factors may lead to the stress fracture of the adaptor.
Event or Problem Description
A patient underwent tka surgery on (b)(6) 2024.The patient began experiencing noise during knee movement after surgery; a revision surgery was performed on (b)(6) 2024.The hinge constructure failure of implants was observed.

• 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, 30075
• MDR Report Key: 25038509
• Report Number: 9681642-2026-00016
• Device Sequence Number: 13364927
• Product Code: KRO
• UDI-Device Identifier: 04719872179443
• UDI-Public: 04719872179443
• 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: 2023
• 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: 2115-3410 / 2315-3241
• Device Lot Number: 23J481A / 23H148A
• 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: 10/13/2023
• 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 Sex: Unknown