MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATIONS USTAR II KNEE SYSTEM SEGMENT PART, RHS, 25 MM LENGTH; ONCOLOGY KNEE SYSTEM SEGMENT

Model Number	2915-1025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation into the cause of the adverse event is in progress.
Event or Problem Description
Upon x-ray evaluation dr.Tuttle determined the 25-mm segment on the femoral side had broken.A revision surgery was scheduled, and the 25-mm segment was successfully extracted and replaced with a united 30-mm segment on (b)(6) 2023.
Additional Manufacturer Narrative
Based on the analysis results revealed that the device was suspected to break due to fatigue damage.The device is confirmed to conform to the safety requirement and has received its 510(k) clearance.To increase the safety of the device, the design change was finished.The safety of the subject device increased from 1.03 to 1.25 under the hip joint loading condition and from 1.17 to 1.26 under the knee joint loading condition.
Event or Problem Description
Upon x-ray evaluation dr.(b)(6) determined the 25-mm segment on the femoral side had broken.A revision surgery was scheduled, and the 25-mm segment was successfully extracted and replaced with a united 30-mm segment on (b)(6) 23.

• Brand Name: USTAR II KNEE SYSTEM SEGMENT PART, RHS, 25 MM LENGTH
• Common Device Name: ONCOLOGY KNEE SYSTEM SEGMENT
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATIONS; no 57, park ave 2; hsinchu city, 30075 ; TW 30075
• Manufacturer (Section G): UNITED ORTHOPEDIC CORPORATION; no 57, park ave 2; hsinchu city, 30075 ; TW 30075
• Manufacturer Contact: lois ho ; no. 57, park ave 2,; science park; hsinchu city, 30075 ; TW 30075
• MDR Report Key: 17222914
• Report Number: 9681642-2023-00001
• Device Sequence Number: 7097902
• Product Code: KRO
• UDI-Device Identifier: 04719872148197
• UDI-Public: (01)04719872148197(17)250513(10)18D446A1
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2025
• Device Model Number: 2915-1025
• Device Catalogue Number: 2915-1025
• Device Lot Number: 18D446A1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2023
• Supplement Date Received by Manufacturer: 06/10/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2020
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male