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

Model Number	25001208
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report was performed past the 30 days of awareness due to human error (incorrect decision made).It was detected during internal complaint management controls.This event is related to the manufacturer reference numbers (b)(4) (all three reported late).
Event or Problem Description
Allegedly, the patient underwent an irrigation and debridement procedure due to an infection.Components not revised: resurfacing femur catalog number 2500l004 lot number: 1744129; canal filling stem extension: catalog number ksp17140 lot number: 0952811091690600; tibial sleeve catalog number: 25002205 lot number: 0644473001767219; canal filling stem extension catalog number: ksp16100 lot number: 15424491757475.

• 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: 12292012
• Report Number: 3010536692-2021-00437
• Device Sequence Number: 4448425
• Product Code: JDI
• UDI-Device Identifier: M684250012081
• UDI-Public: M684250012081
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K013035
• 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,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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: 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: 05/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 08/06/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR