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

Catalog Number	2315-3216
Medical Device Problem Codes	Loss of Osseointegration (2408); Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injection Site Reaction (4562)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's knee joint exhibited hyperextension of up to 10 degrees for a long time, and it is suspected a femoral fracture prior implant loosening which likely caused abnormal loading.Since it cannot be determined whether the femoral fracture and implant loosening occurred prior to the yoke breakage, the causal relationship between the fracture, implant loosening, and yoke breakage cannot be confirmed.
Event or Problem Description
A patient underwent a tka surgery on (b)(6) 2024.A revision surgery was conducted on (b)(6) 2025 due to knee joint instability.Pre-operative x-rays showed yoke brakeage, and the femoral component loosening was observed during the surgery.

• 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, 30075 ; TW 30075
• Manufacturer Contact: lois ho ; no. 57.,park ave 2.,science park; hsinchu city 30075,taiwan; hsinchu, 30075
• MDR Report Key: 25038511
• Report Number: 9681642-2026-00021
• Device Sequence Number: 10411451
• Product Code: KRO
• UDI-Device Identifier: 04711605580359
• UDI-Public: 04711605580359
• 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: 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: 2315-3216
• Device Lot Number: 21D089A
• 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: 04/22/2021
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 72 KG