MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION TIB KEELED NONPOROUS; KNEE COMPONENT

Model Number ETPKN4SX

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)

Event Type  Injury  

Event Description

Allegedly, patient is feeling pain and swelling she was tested for metal allergies and it was positive.She has not been revised yet.

Manufacturer Narrative

The previous report was submitted alongside with the investigation for metal on metal hip complaints.This was a mistake please disregard that information and find the correct investigation codes.

• Brand Name: EVOLUTION TIB KEELED NONPOROUS
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9660266
• MDR Text Key: 177808040
• Report Number: 3010536692-2020-00096
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ETPKN4SX
• Device Catalogue Number: ETPKN4SX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2020
• Date Manufacturer Received: 01/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention