MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CS INSRT IMPL SZ 3 LEFT 10MM IMPLANT PARTNERS; KNEE COMPONENT

Model Number EAI3110LWD

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the patient was implanted with the evolution nitrix (tibial and femoral components) but surgery was completed without a tibia insert because the hospital only had implant partner inserts available which are not indicated for use with the evolution nitrix.The insert was later implanted which would work with the tibial and femoral components.There was a secondary surgery due to a non-compatible insert for the original surgery.

Manufacturer Narrative

Update incident date and event problem codes.This event was also reported under 3010536692-2020-00238.

• Brand Name: CS INSRT IMPL SZ 3 LEFT 10MM IMPLANT PARTNERS
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9835696
• MDR Text Key: 183882405
• Report Number: 3010536692-2020-00239
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EAI3110LWD1
• UDI-Public: M684EAI3110LWD1
• Combination Product (y/n): N
• PMA/PMN Number: K113325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EAI3110LWD
• Device Catalogue Number: EAI3110LWD
• Device Lot Number: 15220061596738.
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2020
• Date Manufacturer Received: 02/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention