MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM RIGH; KNEE COMPONENT

Model Number EIS6S10R

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to infection.Srnjr number: 5373470, side: r, gender: m.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM RIGH
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18961600
• MDR Text Key: 338384606
• Report Number: 3010536692-2024-00142
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS6S10R1
• UDI-Public: M684EIS6S10R1
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EIS6S10R
• Device Catalogue Number: EIS6S10R
• Device Lot Number: 1966787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male