MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP FEM CS/CR NON-POR SIZE 4 PRIMARY RIGH; KNEE COMPONENT

Model Number EFSRN4PR

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

This event will be updated when the investigation is complete.

Event Description

Allegedly, patient was revised due to infection.

Manufacturer Narrative

Updated explant-implant dates and evaluation codes.

• Brand Name: EVOLUTION®MP FEM CS/CR NON-POR SIZE 4 PRIMARY RIGH
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9227072
• MDR Text Key: 163609088
• Report Number: 3010536692-2019-01120
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EFSRN4PR1
• UDI-Public: M684EFSRN4PR1
• Combination Product (y/n): N
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EFSRN4PR
• Device Catalogue Number: EFSRN4PR
• Device Lot Number: 1670974
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2019
• Date Manufacturer Received: 09/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR