MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATIONS U-STAR 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	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ustar ii 25 mm segment was reported as broken and the device was returned for evaluation.The manufacturing data of this device was verified and met the design specification.The original design met design, testing and safety requirements and received 510(k) clearance.However, the fracture condition of the returned device was inconsistent with fatigue testing results which follow by norms.Based on one failure, it was determined to increase the design fracture of safety to a higher level on the 25 mm segment.The modified design had increased the factor of safety to account for possible conditions the parts might see that are outside the norms of standard testing protocols.
Event or Problem Description
Per the patient they felt they broke something while walking on a level surface.Upon x-ray evaluation it was determined the 25mm segment had fractured.Dr.(b)(6) performed a left revision surgery and ex-planted the 25mm segment.
Additional Manufacturer Narrative
Additional evaluation of the complained device,devices in the same lot, devices of the same size and a different lot were evaluated via documentation review as well as biomechanical testing.The manufacturing data of this device were verified and met the design specification.Observing the returned device,the fracture condition was inconsistent with fatigue testing results which follow by norms.According to above investigation, this device met design, testing and safety requirements, referring it was a single case caused by uncertain clinically factors.
Event or Problem Description
Per the patient they felt they broke something while walking on a level surface.Upon x-ray evaluation it was determined the 25mm segment had fractured.Dr.Hillock performed a left revision surgery and ex-planted the 25mm segment.

• Brand Name: U-STAR II KNEE SYSTEM SEGMENT PART, RHS, 25 MM LENGTH
• Common Device Name: ONCOLOGY KNEE SYSTEM SEGMENT
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATIONS; hsinchu city, ; TW
• Manufacturer Contact: lois ho ; no 57, park ave 2,; science park; hsinchu city, 30075 ; TW 30075
• MDR Report Key: 13510462
• Report Number: 9681642-2022-00001
• Device Sequence Number: 14492746
• Product Code: KRO
• UDI-Device Identifier: 04719872148197
• UDI-Public: (01)04719872148197(17)241009(10)16E546A11
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: 10/09/2024
• Device Model Number: 2915-1025
• Device Catalogue Number: 2915-1025
• Device Lot Number: 16E546A11
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 77 KG