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

Model Number	EFSAN2PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fluid Discharge (2686)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly,the patient (assuming we are talking about a size 2 set of implants) was small framed female.Sales rep is told that exposure was extremely difficult and dr struggled thru the entire case.The cement technique was poor and there was a considerable amount of liquid and fluids present in the wound during application of the cement.The case was a bilateral surgery.He believes both devices required revision in a short period of time following the primary case.It is not confirmed that the devices have been already revised.No part numbers or lot numbers for the devices have been received however, it is indicated that the set of nitrx implants are size number 2.The event regarding the devices implanted on patient's right side are captured under microport orthopedics group number:(b)(4).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: EVOLUTION® NITRX? FEM CS/CR
• 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: 15905596
• Report Number: 3010536692-2022-00431
• Device Sequence Number: 5762856
• Product Code: JWH
• UDI-Device Identifier: M684EFSAN2PL1
• UDI-Public: M684EFSAN2PL1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: EFSAN2PL
• Device Catalogue Number: EFSAN2PL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/03/2023
• 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