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

Model Number EFSAN6PL

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Inflammation (1932); Pain (1994); Fluid Discharge (2686)

Event Date 09/25/2022

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event 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) however it was indicated that only the components implanted in her left knee have the alleged complaint stated above.The following components were implanted in her right knee.None of these components have been revised and they have not an alleged deficiency against them: product id: efsan6pr, evolution® nitrx? fem cs/cr nonpor tinbn coated size 6 primary right, lot: 1845071 qty:1.Product id: etakn6sr, evolution® nitrx? tib keeled nonpor tinbn coated size 6 primary right, lot: 1779335, qty:1.Product id: eis6s10r, evolution® mp? cs insert size 6 standard 10mm right, lot: 1837933, qty:1.Product id: kpontp35, advance® onlay all-poly patella 35mm tri-peg, lot: 1843408, qty:1.Also, the following instrument was used in her right knee implant surgery without any complaint stated against it: product id: k0001288, advance® evolution® pin pack 3 long & 2 collared sterile, lot: 1851294, qty:1.

• Brand Name: EVOLUTION® NITRX? FEM CS/CR
• Type of Device: 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: 15743380
• MDR Text Key: 303233284
• Report Number: 3010536692-2022-00390
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: M684EFSAN6PL1
• UDI-Public: M684EFSAN6PL1
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EFSAN6PL
• Device Catalogue Number: EFSAN6PL
• Device Lot Number: 18450701853258
• 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
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female