MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 5+ 10MM LEFT; KNEE COMPONENT

Model Number	EIS5P10L
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/08/2020
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, tibia insert would not lock on tibia tray.This was repeated three times and insert came out after all attempts.
Additional Manufacturer Narrative
Updated event problem codes.This event did not involve a serious injury.No trauma to the patient occurred and surgery time extended no more than 30 minutes.This event was reported as a product problem.

• Brand Name: EVOLUTION MP CS INSERT SIZE 5+ 10MM LEFT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10005329
• Report Number: 3010536692-2020-00351
• Device Sequence Number: 2968715
• Product Code: HRY
• UDI-Device Identifier: M684EIS5P10L1
• UDI-Public: M684EIS5P10L1
• Combination Product (Y/N): N
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: EIS5P10L
• Device Catalogue Number: EIS5P10L
• Device Lot Number: 1803782
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 10/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other