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

Model Number DIAM 36MM FOR 29MM BASEPLATE

Device Problems Disassembly (1168); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Surgeon did an ascend reversed on (b)(6) 2016, he did the procedure perfectly as we describe in our technique.After one year, patient came back with shoulder pain without any trauma occurred.The glenosphere came loose from the baseplate.The surgeon did a revision surgery on (b)(6) 2018 and replaced it for a new glenosphere.

Manufacturer Narrative

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

• 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: 7352160
• MDR Text Key: 102849377
• Report Number: 3000931034-2018-00039
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935886
• UDI-Public: 03700386935886
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/01/2021
• Device Model Number: DIAM 36MM FOR 29MM BASEPLATE
• Device Catalogue Number: DWD190
• Device Lot Number: AA7324
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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
• Patient Weight: 73