MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR TAPERED HIP STEM; HIP COMPONENT

Model Number PHA00411

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly, patient scheduled to be revised due to unknown complications.

Manufacturer Narrative

Updated information received on (b)(6)2019: from received x-ray, the patient suffered from periprosthetic fracture around the stem.Updated device and patient codes.

• Brand Name: PROFEMUR TAPERED HIP STEM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8727998
• MDR Text Key: 148984455
• Report Number: 3010536692-2019-00835
• 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,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA00411
• Device Catalogue Number: PHA00411
• Device Lot Number: 067439174
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/28/2019
• Date Manufacturer Received: 05/28/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention