MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOID SPHERE

Device Problems Disassembly (1168); Material Separation (1562)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The glenosphere dissociated from the baseplate while the patient was driving a car.Until the incident the patient had an excellent result.He was totally pain free and had a full range of motion with normal function.The failure happened.

Manufacturer Narrative

Root cause of reported event could not be confirmed.Link with the device highly improbable but rather due to a misuse.This is the final report submitted regarding this surgical event and medical device.

Event Description

The glenosphere dissociated from the baseplate while the patient was driving a car.Until the incident the patient had an excellent result.He was totally pain free and had a full range of motion with normal function (he practiced swimming).The failure happened.

• Brand Name: AEQUALIS REVERSED GLENOID SPHERE
• Type of Device: AEQUALIS REVERSED GLENOID SPHERE
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo-sanchez ; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330 ; 56523528
• MDR Report Key: 5172006
• MDR Text Key: 29804766
• Report Number: 3000931034-2015-00175
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• 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