MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN® TIBIAL SLEEVE SIZE 3; KNEE COMPONENT

Model Number	25002203
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, the patient has developed an infection and when reviewing the post bill, it was identified that the patient has a guardian tibial sleeve with plugs implanted.The patient also has the following implants placed that are eleos: poly spacer, distal femur, tibial hinge component, distal femur axial pin, stem extension, three male-female midsections, proximal femur, and male-male midsection.The patient will be undergoing a revision surgery where all implanted devices will be explanted and an onkos my3d custom case will be implanted.This revision surgery has not been scheduled yet.

• Brand Name: GUARDIAN® TIBIAL SLEEVE SIZE 3
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 17843390
• Report Number: 3010536692-2023-00175
• Device Sequence Number: 12556023
• Product Code: JDI
• UDI-Device Identifier: M684250022031
• UDI-Public: M684250022031
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K013035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023

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: 25002203
• Device Catalogue Number: 25002203
• Device Lot Number: 1884550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown