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

Model Number	EAI3110LWD
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
Event or Problem 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.
Additional Manufacturer Narrative
Update incident date and event problem codes.This event was also reported under 3010536692-2020-00239.

• Brand Name: CS INSRT IMPL SZ 3 LEFT 10MM IMPLANT PARTNERS
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9835639
• Report Number: 3010536692-2020-00238
• Device Sequence Number: 19017749
• Product Code: HRY
• UDI-Device Identifier: M684EAI3110LWD1
• UDI-Public: M684EAI3110LWD1
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K113325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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
• Operator of Device: Other
• Device Model Number: EAI3110LWD
• Device Catalogue Number: EAI3110LWD
• Device Lot Number: 15348551596458
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 10/07/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention