MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP FEM CS/CR POROUS; KNEE COMPONENT

Model Number	EFSRP6PL
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Insufficient Information (4580)
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, revised for broken loose tibia and femur easily removed.
Additional Manufacturer Narrative
Additional information received for this event on 6/3/2022.Patient had two traumatic events (injured from riding a scooter and then stepped in a pothole) which led to the revision surgery.Therefore, this manufacturer report number: (b)(4) is considered no longer reportable since the adverse event was caused by the traumatic events and there´s no alleged deficiency against the devices.Please void this report.

• Brand Name: EVOLUTION®MP FEM CS/CR POROUS
• 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: 12738752
• Report Number: 3010536692-2021-00557
• Device Sequence Number: 4713631
• Product Code: JWH
• UDI-Device Identifier: M684EFSRP6PL1
• UDI-Public: M684EFSRP6PL1
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 08/03/2022

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: EFSRP6PL
• Device Catalogue Number: EFSRP6PL
• Device Lot Number: 1728113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 10/21/2021; 10/21/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 02/23/2022; 08/03/2022
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 61 KG