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

Model Number	EIS6S10R
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9577959
• Report Number: 3010536692-2020-00031
• Device Sequence Number: 2866589
• Product Code: HRY
• UDI-Device Identifier: M684EIS6S10R1
• UDI-Public: M684EIS6S10R1
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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: Health Professional
• Device Model Number: EIS6S10R
• Device Catalogue Number: EIS6S10R
• Device Lot Number: 1754348
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 01/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR