MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR SIZE 4 STANDARD RIG; KNEE COMPONENT

Model Number ETPKN4SR

Device Problems Unstable (1667); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, patient underwent right tkr on (b)(6) 2017.Base plate subsided into tibia resulting in significant valgus and instability.Patient revised on (b)(6) 2021 with evolution revision tibial base and stem extensions.Liner replaced with a 20mm one.(b)(6) - (b)(4).

Manufacturer Narrative

Added medical device problem code: 4003.

• Brand Name: EVOLUTIONMP TIB KEELED NONPOR SIZE 4 STANDARD RIG
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11457066
• MDR Text Key: 239078238
• Report Number: 3010536692-2021-00149
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN4SR1
• UDI-Public: M684ETPKN4SR1
• Combination Product (y/n): N
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ETPKN4SR
• Device Catalogue Number: ETPKN4SR
• Device Lot Number: 1700286
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2021
• Date Manufacturer Received: 02/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR