MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. HEAD; HIP COMPONENT

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

Allegedly, patient revised due to mom complications.Right.

Manufacturer Narrative

This event was found to be a duplicate already reported under 3010536692-2018-00654 and 3010536692-2018-00655.Please void the initial report.

• Brand Name: HEAD
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8409632
• MDR Text Key: 138445948
• Report Number: 3010536692-2019-00538
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• 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: 02/11/2019
• Date Manufacturer Received: 02/11/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention