MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION CUP

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once investigation is complete.

Event Description

Allegedly, patient revised due unknown complications.No additional information provided.

Manufacturer Narrative

Please void this report.Additional advisement received on september 9th, 2019 that changes the reportability status for this product.This product has no alleged deficiency per the complaint description.Therefore, this incident is non-reportable.

• Brand Name: EVOLUTION CUP
• Type of Device: CUP
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8660382
• MDR Text Key: 146719383
• Report Number: 3010536692-2019-00801
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2019
• Date Manufacturer Received: 05/01/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention