MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM RIGH; KNEE COMPONENT

Model Number EIS6S10R

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Allegedly, patient underwent right total knee replacement on (b)(6) 2018, revised on (b)(6) 2019 due to instability, 10mm tibial insert increased to 17mm.While revising the surgeon decided to reduce the patella from 35mm to 32mm.(b)(6).

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM RIGH
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 9577959
• MDR Text Key: 174879088
• Report Number: 3010536692-2020-00031
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS6S10R1
• UDI-Public: M684EIS6S10R1
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EIS6S10R
• Device Catalogue Number: EIS6S10R
• Device Lot Number: 1754348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2019
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR