MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB; KNEE COMPONENT

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Reaction (1733); Hypersensitivity/Allergic reaction (1907); Swelling (2091); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Allegedly, she is having swelling of her knee since her surgery in 2013.Her watch also made her break out so she believes she is allergic to certain metals and her doctor wants this information prior to testing.

Manufacturer Narrative

Please disregard the previous evaluation codes reported and investigation attached.All codes on section h6 had been updated to reflect the investigation of this event.

• Brand Name: EVOLUTIONMP TIB
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9871891
• MDR Text Key: 186294359
• Report Number: 3010536692-2020-00272
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2020
• Date Manufacturer Received: 03/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention