MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN RESURFACING FEMUR AXIAL PIN SIZE 4; KNEE COMPONENT

Model Number 25002114

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 RESURFACING FEMUR AXIAL PIN SIZE 4
• 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: 12292021
• MDR Text Key: 265564848
• Report Number: 3010536692-2021-00438
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684250021141
• UDI-Public: M684250021141
• 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: 25002114
• Device Catalogue Number: 25002114
• Device Lot Number: 1614168
• 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
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR