MAUDE Adverse Event Report: AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS

Model Number CENTERED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Reaction (2414)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.

Event Description

"on (b)(6) 2019 i had a left reverse shoulder replacement with wright components aequalis glenoid baseplate and aequalis reversed centered glenoid sphere.On (b)(6) 2019, and to this day, have developed a red rash, nothing raised and very itchy.It comes out on different areas of my body, one side of my face is completely red and swollen.I have been to a dermatologist, emergency room and no one knows the cause.The only thing different is my prosthetic implant.My diet has not changed, my daily living has not changed.".

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED GLENOID SPHERE
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer Contact: maud andriollo ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• MDR Report Key: 9530032
• MDR Text Key: 179621374
• Report Number: 3000931034-2019-00192
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CENTERED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other