MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION TIB OFFSET ADAPTER4MM X 25MM; KNEE INSTRUMENT

Model Number	ESRK0425
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient was revised due to infection.

• Brand Name: EVOLUTION TIB OFFSET ADAPTER4MM X 25MM
• Common Device Name: KNEE INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11306629
• Report Number: 3010536692-2021-00074
• Device Sequence Number: 19110495
• Product Code: JWH
• UDI-Device Identifier: M684ESRK04251
• UDI-Public: M684ESRK04251
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 02/10/2021

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: ESRK0425
• Device Catalogue Number: ESRK0425
• Device Lot Number: 1764927
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention