MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 6+ 10MM RIGHT; KNEE COMPONENT

Model Number	EIS6P10R
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent bilateral tkr on (b)(6) 2016.Right knee revised on (b)(6) 2020 due to infection.Performed washout and 10mm insert replaced with 12 mm.(b)(6).

• Brand Name: EVOLUTION MP CS INSERT SIZE 6+ 10MM RIGHT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11362074
• Report Number: 3010536692-2021-00102
• Device Sequence Number: 19693878
• Product Code: HRY
• UDI-Device Identifier: M684EIS6P10R1
• UDI-Public: M684EIS6P10R1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

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: EIS6P10R
• Device Catalogue Number: EIS6P10R
• Device Lot Number: 1590205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 02/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR