MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION DISTAL FEMORAL COMPONENT, RHS, S, RIGHT / SEGMENT PART,RHS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	2115-3410 / 2915-1030
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002); Misassembled During Installation (4049)
Health Effect - Clinical Codes	Joint Dislocation (2374); Subluxation (4525)
Date of Event	07/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the investigation, no dimensional deviations were found in either the distal femoral component or the segment compartment.The possible root cause of failure was the inadequate alignment of the two components during assembly.As a corrective action, the alignment markings have been deepened to help the surgeon to align the distal femoral component with segment, thereby preventing inadequate alignment.
Event or Problem Description
A patient underwent an implantation with ustar ii knee system and experienced a dissociation of the ustar ii distal femoral component on (b)(6) 2020.A revision surgery was conducted on (b)(6) 2020.

• Brand Name: DISTAL FEMORAL COMPONENT, RHS, S, RIGHT / SEGMENT PART,RHS
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; hsinchu city, taiwan; hsinchu city, ; TW
• Manufacturer Contact: lois ho ; no 57, park ave 2, science park,; hsinchu city 30075, taiwan; hsinchu city,
• MDR Report Key: 25038504
• Report Number: 9681642-2026-00009
• Device Sequence Number: 10410983
• Product Code: KRO
• UDI-Device Identifier: 04719872179443
• UDI-Public: 04719872179443
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• 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 / 2915-1030
• Device Lot Number: 20A141A / 18D446B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown