MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 10MM RIGH; KNEE COMPONENT

Model Number EIS5S10R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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 idaho 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 mike shatzer(sales rep) saying that a doc in idaho 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 (b)(6) 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.It is indicated that the patient has not had any of the components removed, so revision surgery has not been performed.

Manufacturer Narrative

Please see attached document.

Manufacturer Narrative

After further analysis of this event from reliability engineering, it has been determined that this device should be considered as no complaint stated since there's not an alleged deficiency against the insert.It is identified that the complaint is against the nitrix components.Please void this report.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 10MM RIGH
• 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: 15668401
• MDR Text Key: 302400899
• Report Number: 3010536692-2022-00375
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS5S10R1
• UDI-Public: M684EIS5S10R1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093552
• 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,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIS5S10R
• Device Catalogue Number: EIS5S10R
• Device Lot Number: 1877949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2022
• Date Manufacturer Received: 10/05/2022
• 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: 60 YR
• Patient Sex: Female