MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN TIBIAL HINGE BASE W/ ROTATIONAL STOP PIN; KNEE COMPONENT

Model Number	25002100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/09/2020
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, patient underwent a revision surgery due to the hinge component fracturing.Additional information received on 09/16/2020 : adding product information.
Additional Manufacturer Narrative
Reason for voided: guardian component is not reportable by microport orthopedics.
Additional Manufacturer Narrative
There was an error found in the assessment of the reportability of this event.Updated implantation date and evaluation codes.

• Brand Name: GUARDIAN TIBIAL HINGE BASE W/ ROTATIONAL STOP PIN
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10656239
• Report Number: 3010536692-2020-00638
• Device Sequence Number: 14257867
• Product Code: JDI
• UDI-Device Identifier: M684250021001
• UDI-Public: M684250021001
• 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 Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2021

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: 25002100
• Device Catalogue Number: 25002100
• Device Lot Number: 1519850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/15/2020; 09/15/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/27/2020; 03/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR