MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® NITRX? TIB KEELED; KNEE COMPONENT

Model Number ETAKN6SL

Device Problem Loss of Osseointegration (2408)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2024

Event Type  Injury  

Event Description

Allegedly, revised due to loosening.Fourth case seen by the doctor with zero cement bonded to the baseplate.

Manufacturer Narrative

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

• Brand Name: EVOLUTION® NITRX? TIB KEELED
• 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: 19034366
• MDR Text Key: 339269696
• Report Number: 3010536692-2024-00157
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: M684ETAKN6SL1
• UDI-Public: M684ETAKN6SL1
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ETAKN6SL
• Device Catalogue Number: ETAKN6SL
• Device Lot Number: 1871745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male