MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX REVERSED INSERT; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	DIAM 36MM TH+6 A 12.5
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
"ascend flex reversed tray/liner have rotated from their original position.On x-ray and ct this looked to be the liner rotating inside the tray, however it was probably the reversed tray rotating in the stem.The joint had become unstable and had to be revised.This required implantation of a new reverse tray and liner.The flex stem was found to be well fixed, and did not require revising.At the original surgery, the reversed tray was assembled to the flex stem on the back table.Both the surgeon and the sales rep present are happy all correct surgical steps and techniques were followed.".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS ASCEND FLEX REVERSED INSERT
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7052192
• Report Number: 3000931034-2017-00193
• Device Sequence Number: 16416777
• Product Code: KWS
• UDI-Device Identifier: 03700386940507
• UDI-Public: 03700386940507
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 05/25/2022
• Device Model Number: DIAM 36MM TH+6 A 12.5
• Device Catalogue Number: DWF361B
• Device Lot Number: AB13680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other