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

Model Number 26000006

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly, worn poly, we swapped out head liner for new ones.This primary was not done in our territory we could not find out what was in the patient before hand we had to go off an xray date.

Manufacturer Narrative

Upon investigation it was found no alleged deficiency against this component.Please void this report.

• Brand Name: CERAMIC FEMORAL HEAD
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9203748
• MDR Text Key: 162979228
• Report Number: 3010536692-2019-01104
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P030027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

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
• Device Operator: Other
• Device Model Number: 26000006
• Device Catalogue Number: 26000006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2019
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 02/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention