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

Catalog Number	2315-3213
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Hyperextension (4523)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the analysis, it is hypothesized that the patient may have anterior tilting of the distal femoral component during knee movement, which affects the hyperextension stop mechanism and lead to the tibial insert screw fracture.
Event or Problem Description
A patient underwent the total knee joint replacement on (b)(6) 2022.Two years postoperatively, the patient reported a sensation of dislocation without history of falls, collisions, or strenuous activity.During a revision surgery performed on (b)(6) 2024, the retrieved implant revealed that the tibial insert component had fractured.

• Brand Name: USTAR II KNEE SYSTEM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no57, 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: 25038503
• Report Number: 9681642-2026-00014
• Device Sequence Number: 10410982
• Product Code: KRO
• UDI-Device Identifier: 04711605580328
• UDI-Public: 04711605580328
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: 2315-3213
• Device Lot Number: 20L074A
• 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: 11/20/2020
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 46 KG
• Patient Race: Asian