MAUDE Adverse Event Report: United Orthopedic Corporation USTAR II Hip System; Hip Implant

Model Number	1115-9220
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury

• Brand Name: USTAR II Hip System
• Common Device Name: Hip Implant
• Manufacturer (Section D): United Orthopedic Corporation; no 57, park ave.2,; science park; hsinchu city, 30007 5; TW 300075
• MDR Report Key: 50745265
• Report Number: 3009760038-2026-00005
• Device Sequence Number: 18697400
• Product Code: LPH
• UDI-Device Identifier: 04711605584180
• UDI-Public: 04711605584180
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026
• Report Date (Section F): 09/10/2026

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 Expiration Date: 08/24/2026
• Device Model Number: 1115-9220
• Device Lot Number: 20L485E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/10/2026
• Device Age: 40 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/10/2026