MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE STATURE FEMUR SIZE 3 RIGHT NONPOR; KNEE COMPONENT

Model Number	KFTCNN3R
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to aseptic loosening femur| aseptic loosening tibia revision njr number: (b)(4), side: r, primary asa: p2 - mild disease not incapacitating.Mhra reference no: (b)(4).

• Brand Name: ADVANCE STATURE FEMUR SIZE 3 RIGHT NONPOR
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11992510
• Report Number: 3010536692-2021-00328
• Device Sequence Number: 3201770
• Product Code: JWH
• UDI-Device Identifier: M684KFTCNN3R1
• UDI-Public: M684KFTCNN3R1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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: KFTCNN3R
• Device Catalogue Number: KFTCNN3R
• Device Lot Number: 1545565
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention