MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN STRAIGHT STEM 11MM X 152MM TITANIUM; KNEE COMPONENT

Model Number	25000011
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
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, there was unstable construct.

• Brand Name: GUARDIAN STRAIGHT STEM 11MM X 152MM TITANIUM
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11401656
• Report Number: 3010536692-2021-00130
• Device Sequence Number: 11895129
• Product Code: JDI
• UDI-Device Identifier: M684250000111
• UDI-Public: M684250000111
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K013035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2021

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: Other
• Device Model Number: 25000011
• Device Catalogue Number: 25000011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/08/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention