MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® PRIMARY FEMORAL SIZE 4 RIGHT NONPOROUS; KNEE COMPONENT

Model Number	KFTCNP4R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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, fracture of the femoral component of the tkr, additionally the tibial component had wear from the femoral fracture, all components were revised.
Additional Manufacturer Narrative
Due to additional information received, the following updates have been done for this report: 1- incident description has had a minor update in section b.5.2- lot number has been updated in section d.4.3- section d.9 has been updated.
Event or Problem Description
Allegedly, the patient experienced pain and fracture of the femoral component.Additionally, the tibial insert has worn from articulation with the fractured femoral component.All components were revised.

• Brand Name: ADVANCE® PRIMARY FEMORAL SIZE 4 RIGHT NONPOROUS
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 13690645
• Report Number: 3010536692-2022-00066
• Device Sequence Number: 20085824
• Product Code: JWH
• UDI-Device Identifier: M684KFTCNP4R1
• UDI-Public: M684KFTCNP4R1
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K972626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 05/25/2022

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: KFTCNP4R
• Device Catalogue Number: KFTCNP4R
• Device Lot Number: 0311335278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male