MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR NECK; HIP COMPONENT

Model Number PHAX12XX

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the doctor noted a fracture of a modular neck of his hip prosthesis, a surgical revision was performed consisting of a change of the entire femoral implant.

Manufacturer Narrative

No further information was received for this event.

• Brand Name: PROFEMUR MODULAR NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11358218
• MDR Text Key: 232843414
• Report Number: 3010536692-2021-00100
• Device Sequence Number: 1
• Product Code: MRA
• 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: 04/22/2021

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: PHAX12XX
• Device Catalogue Number: PHAX12XX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 04/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR