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

Model Number	ETAKN5SL
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Fluid Discharge (2686)
Date of Event	09/25/2022
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, reporter became aware of some nitrx complaints from a surgeon in (b)(6) however, no information about the complaints were given to reporter.Microport orthopedics vp r&d prod.Development stated that he received a phone call from (b)(6) (sales rep) saying that a doc in (b)(6) had a few patients come back in with painful, swollen knees.He contacted the rep to see if he could get more details.He asked a series of questions that he did not know the answer.No part/lot numbers are given and it has not been indicated how many events/patients have occurred regarding these issues.Additional information received on 10/05/2022 and 10/13/2022: a total of 8 complaints were received with all relevant information included in each incident form.The 7 remaining complaints are captured under different microport incident group numbers.Allegedly, recurring knee effusion.No infection to date.It was confirmed that each of these patients were seen for follow-up appointments to address inflammation in their knees.The surgeon confirmed that none of the patients had infections and that their knees had fluid buildup that was drained.The surgeon has not been able to determine if these events were caused by an alleged deficiency/failure against these devices or if they were caused due to patient conditions.It is indicated that there is no access to information regarding each patient's condition, activity level, medical history, etc.No indications of revision surgery performed/components removed have been given yet.This patient has components implanted in both knees (right and left).It was indicated that both of his knees have the alleged complaint stated above.The complaint for the right components is captured under microport orthopedics incident group number: (b)(4).

• Brand Name: EVOLUTION® NITRX? TIB KEELED
• 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: 15743590
• Report Number: 3010536692-2022-00399
• Device Sequence Number: 7074408
• Product Code: JWH
• UDI-Device Identifier: M684ETAKN5SL1
• UDI-Public: M684ETAKN5SL1
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/22/2022

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: ETAKN5SL
• Device Catalogue Number: ETAKN5SL
• Device Lot Number: 1817300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/22/2022
• 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: 67 YR
• Patient Sex: Male