MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION CEMENTED STEM EXT17MM X 25MM; FEMORAL COMPONENT

Model Number ESC17025

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, when opening the stem extension (esc17025), after opening the double sterilization pack, the silicon wrapped to protect the product was crimped to the product.

Manufacturer Narrative

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 CEMENTED STEM EXT17MM X 25MM
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; arlington TN
• MDR Report Key: 10004771
• MDR Text Key: 189597872
• Report Number: 3010536692-2020-00350
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ESC17025
• Device Catalogue Number: ESC17025
• Device Lot Number: 1782270
• 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