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

Model Number 36MM FOR 25MM BASEPLATE

Device Problems Device Difficult to Setup or Prepare (1487); Device Issue (2379)

Patient Problem Failure of Implant (1924)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"while preparing the prosthesis, it was not possible to screw the thread of the glenosphere into the internal thread of the baseplate.Another glenosphere was used, supposing that the screw thread was dull.Screwing remained impossible.At the end, another baseplate was used, together with a new glenosphere : success.An additional delay of 30 minutes was required to complete the surgery".

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-sanchez ; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7428325
• MDR Text Key: 105666804
• Report Number: 3000931034-2018-00048
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935824
• UDI-Public: 03700386935824
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/07/2023
• Device Model Number: 36MM FOR 25MM BASEPLATE
• Device Catalogue Number: DWD180
• Device Lot Number: AB7303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• 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