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

Model Number 25001208

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 05/13/2021

Event Type  Injury  

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 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
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 12292012
• MDR Text Key: 265546515
• Report Number: 3010536692-2021-00437
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684250012081
• UDI-Public: M684250012081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25001208
• Device Catalogue Number: 25001208
• Device Lot Number: 1762446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2021
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR