MAUDE Adverse Event Report: TORNIER SAS AEQUALIS REVERSED GLENOID SPHERE

Catalog Number DWD193

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dissociation between sphere and baseplate after 1.5 months post-operative.

• Brand Name: AEQUALIS REVERSED GLENOID SPHERE
• Type of Device: AEQUALIS REVERSED GLENOID SPHERE
• Manufacturer (Section D): TORNIER SAS; montbonnot, ; FR
• Manufacturer Contact: segolene pollet ; FR
• MDR Report Key: 5387562
• MDR Text Key: 181536963
• Report Number: 3000931034-2015-00121
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: DWD193
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2015
• Initial Date FDA Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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): Required Intervention