MAUDE Adverse Event Report: TORNIER SAS AEQUALIS REVERSED SHOULDER PROSTHESIS INSERT

Catalog Number DWB993

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 04/30/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Luxation happened on (b)(6) 2015, then cured by closed reduction.Surgeon found there is still instability, and did a revision to replace the glenosphere on (b)(6) 2015.

• Brand Name: AEQUALIS REVERSED SHOULDER PROSTHESIS INSERT
• Type of Device: AEQUALIS REVERSED SHOULDER PROSTHESIS INSERT
• Manufacturer (Section D): TORNIER SAS; montbonnot, ; FR
• Manufacturer Contact: segolene pollet ; FR
• MDR Report Key: 5815091
• MDR Text Key: 176490882
• Report Number: 3000931034-2015-00105
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: DWB993
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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 Age: 77 YR
• Patient Weight: 63