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

Model Number	25001208
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 a poly swap.

• Brand Name: GUARDIAN TIBIAL SLEEVE POLY SPACER 8MM
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11410830
• Report Number: 3010536692-2021-00139
• Device Sequence Number: 11940068
• Product Code: JDI
• UDI-Device Identifier: M684250012081
• UDI-Public: M684250012081
• 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: 25001208
• Device Catalogue Number: 25001208
• 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: 03/04/2021
• Supplement Report FDA Received Date: 04/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention