MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR SIZE 6 STANDARD RIG; KNEE COMPONENT

Model Number	ETPKN6SR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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 (b)(4).Side: r.Primary asa: p2 - mild disease not incapacitating.

• Brand Name: EVOLUTIONMP TIB KEELED NONPOR SIZE 6 STANDARD RIG
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10196831
• Report Number: 3010536692-2020-00422
• Device Sequence Number: 2345502
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN6SR1
• UDI-Public: M684ETPKN6SR1
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ETPKN6SR
• Device Catalogue Number: ETPKN6SR
• Device Lot Number: 1621814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention