MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN TIBIAL SLEEVE POLY SPACER 8MM; KNEE COMPONENT

Model Number	25001208
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
Event or Problem Description
Allegedly, patient underwent a revision surgery due to an alleged infection.

• Brand Name: GUARDIAN TIBIAL SLEEVE POLY SPACER 8MM
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10085667
• Report Number: 3010536692-2020-00376
• Device Sequence Number: 10956671
• Product Code: JDI
• UDI-Device Identifier: M684250012081
• UDI-Public: M684250012081
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K013035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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: Other
• Device Model Number: 25001208
• Device Catalogue Number: 25001208
• Device Lot Number: 1762446
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2020
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/25/2020
• Supplement Report FDA Received Date: 09/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention