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

Model Number EIS5P10L

Device Problems Difficult to Insert (1316); Device Slipped (1584)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, tibia insert would not lock on tibia tray.This was repeated three times and insert came out after all attempts.

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
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10005329
• MDR Text Key: 190502213
• Report Number: 3010536692-2020-00351
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS5P10L1
• UDI-Public: M684EIS5P10L1
• Combination Product (y/n): N
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other