MAUDE Adverse Event Report: UNITED ORTHOPEDIC USTAR SYSTEM; KNEE REPLACEMENT

Model Number	2315-3213, 2115-1330
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that they got out of a chair and experienced pain.They indicated no fall or trauma.Previous ustar ii patient presented with pain and instability.X-ray imaging revealed dislocation of the femoral component and tibial insert yoke and a revision was scheduled.During surgery, surgeon noted the insert screw connecting the femoral component insert and yoke had bent.Original surgery was on (b)(6) 2023 and revision was conducted on (b)(6) 2024.Revision surgery was successfully completed.
Additional Manufacturer Narrative
Importer is attempting to obtain the explanted device and other information for sending to the manufacturer for investigation.

• Brand Name: USTAR SYSTEM
• Common Device Name: KNEE REPLACEMENT
• Manufacturer (Section D): UNITED ORTHOPEDIC; no. 57, park ave. 2; science park; hsinchu city, tw 30075 ; TW 30075
• MDR Report Key: 18665422
• Report Number: 3009760038-2024-00002
• Device Sequence Number: 15522368
• Product Code: KRO
• UDI-Device Identifier: 04719872153900
• UDI-Public: (01)04719872153900(17)270323(10)21D512E11
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2024
• Report Date (Section F): 02/07/2024

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 Model Number: 2315-3213, 2115-1330
• Device Lot Number: 23J82B, 23G030A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/08/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: USTAR FEMORAL COMPONENT, #3, LEFT; XPE TIBIAL INSERT, RS, S, 17 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/07/2024