MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR SIZE 4 STANDARD RIG; KNEE COMPONENT

Model Number	ETPKN4SR
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to infection.Revision njr number: (b)(6).Side: r.Primary asa: p1 - fit and healthy.(b)(4).

• Brand Name: EVOLUTIONMP TIB KEELED NONPOR SIZE 4 STANDARD RIG
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11657301
• Report Number: 3010536692-2021-00200
• Device Sequence Number: 3606486
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN4SR1
• UDI-Public: M684ETPKN4SR1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: ETPKN4SR
• Device Catalogue Number: ETPKN4SR
• Device Lot Number: 1798863
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention