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

Model Number DIAM.42MM FOR 29MM BASEPLATE

Device Problem Disassembly (1168)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/03/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"we did a reversed fracture, for a very difficult case: 3 years old fracture with absence of good bone stock.We implanted a reversed fracture with a 42mm centered glenosphere on a 29mm baseplate.Everything went well and the post op x-ray was perfect! after 3 weeks patient came back after an epileptic attack with an dislocated glenosphere and one dislocated compression screw.Baseplate was still perfectly connected with the native glenoid.But the glenopshere came lose from the baseplate.The surgeon and i know for sure that we connected the central screw in the glenosphere during the 1st surgery.".

• Brand Name: AEQUALIS REVERSED II 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
• Manufacturer Contact: maud andriollo ; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7243734
• MDR Text Key: 99096786
• Report Number: 3000931034-2018-00010
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935916
• UDI-Public: 03700386935916
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/18/2022
• Device Model Number: DIAM.42MM FOR 29MM BASEPLATE
• Device Catalogue Number: DWD193
• Device Lot Number: 6487AS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• 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