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

Model Number PHACXXXX

Device Problem Material Disintegration (1177)

Patient Problem Autoimmune Reaction (1733)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient will be revised due to allergic reaction to cobalt chromium metal ions and particulate debris.

Manufacturer Narrative

Additional information received on 03/18/1010: mpo was informed that the revision surgery was canceled.

• Brand Name: PROFEMUR® COCR MODULAR NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9904759
• MDR Text Key: 186560177
• Report Number: 3010536692-2020-00304
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

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: PHACXXXX
• Device Catalogue Number: PHACXXXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2020
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 06/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention