MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® NITRX? TIB KEELED NONPOR TINBN COATED S; KNEE COMPONENT

Model Number	ETAKN3SR
Medical Device Problem Codes	Difficult to Insert (1316); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, implants removed due to the tibia side not bonding to cement resulting in revisions.Patient experienced pain.

• Brand Name: EVOLUTION® NITRX? TIB KEELED NONPOR TINBN COATED S
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18208449
• Report Number: 3010536692-2023-00217
• Device Sequence Number: 12599030
• Product Code: JWH
• UDI-Device Identifier: M684ETAKN3SR1
• UDI-Public: M684ETAKN3SR1
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: Other
• Device Model Number: ETAKN3SR
• Device Catalogue Number: ETAKN3SR
• Device Lot Number: 1851692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female