MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS

Model Number CENTERED 36MM FOR 25MM BASEPLATE

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The glenoid sphere was found to be unattached from the glenoid base plate via a post-operative x-ray.The patient had a second operation on 02/24/21 to remove the glenoid sphere and replace it with another glenoid sphere.

Manufacturer Narrative

This is the final 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.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS REVERSED GLENOID SPHERE
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 11633046
• MDR Text Key: 244365404
• Report Number: 3000931034-2021-00030
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935824
• UDI-Public: 03700386935824
• Combination Product (y/n): N
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CENTERED 36MM FOR 25MM BASEPLATE
• Device Catalogue Number: DWD180
• Device Lot Number: AD0067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR