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

Device Problem Material Fragmentation (1261)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient was revised due to pain and metallosis.Additional information: right hip.

Manufacturer Narrative

Additional information received on 01/14/2021 please void the following initial and final report mfr report# 3010536692-2020-00110.Since the additional information has determined that this component did not contribute to the incident originally reported.

• Brand Name: PROFEMUR STEM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9695986
• MDR Text Key: 178647176
• Report Number: 3010536692-2020-00110
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/22/2020
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 01/22/2020; 01/22/2020
• Supplement Dates FDA Received: 09/16/2020; 01/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention