MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 8 STANDARD 12MM LEFT; KNEE COMPONENT

Model Number	EIS8S12L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event will be updated once the investigation is complete, trends will be evaluated.
Event or Problem Description
Allegedly, when the surgeon opened the knee up he said that the poly had become loose and wanted to know the amount of force it would take to cause this.When he revised the case, he used a 10mm poly.
Additional Manufacturer Narrative
Updated event description.
Event or Problem Description
Allegedly, when the surgeon opened the knee up he said that the poly had become loose and wanted to know the amount of force it would take to cause this.When he revised the case, he used a 10mm poly.Components not revised.Evolution mp femoral component efsrn8pl 1750275; evolution mp keeled tibial base etpkn8pl 1746908; advanced onlay all poly patella kpontp41 01010471651757454; advanced evolution pin pack 3 long k0001288 1832553.

• Brand Name: EVOLUTION MP CS INSERT SIZE 8 STANDARD 12MM LEFT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9955014
• Report Number: 3010536692-2020-00340
• Device Sequence Number: 11872628
• Product Code: HRY
• UDI-Device Identifier: M684EIS8S12L1
• UDI-Public: M684EIS8S12L1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: EIS8S12L
• Device Catalogue Number: EIS8S12L
• Device Lot Number: 1718470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/26/2020
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 07/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention