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

Model Number 36MM FOR 29MM BASEPLATE

Device Problems Disassembly (1168); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Unspecified Infection (1930)

Event Date 01/09/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"2014 aequalis reversed operation on (b)(6) 2018: the patient fell which may have caused loosening of glenoid sphere and baseplate.As a little swelling and pus were seen in the insertion site, the surgeon decided to remove the implants.On (b)(6) 2018: as the infection was only the surface of the skin, only the glenoid sphere, insert and baseplate were removed and a head was implanted.Comment from surgeon: if infection was very serious, i was going to remove all the implants but it was not so serious, so i just left the stem and implanted a head.This patient seemed to have some kind of infection after the surgery 4 years ago but it did not become serious.So, this component loosening can be the cause of this incident.".

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 (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: 7285262
• MDR Text Key: 100529303
• Report Number: 3000931034-2018-00017
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386916144
• UDI-Public: 03700386916144
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 36MM FOR 29MM BASEPLATE
• Device Catalogue Number: DWB935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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