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

Model Number DIAM. 36MM +6, A-12.5°

Device Problems Unintended System Motion (1430); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019: an initial ascend flex reverse surgery was performed on a patient with a dysfunctional 1/3 of the deltoid muscle and was completed without problems.The position of the tray used at this time was aligned with "#6" in the lateral position.(b)(6) 2020: this patient presented for a periodic check up.No images were available, but x-rays did not reveal any abnormalities.(b)(6) 2020: this patient came to the hospital with complaints of pain.The insert appeared to be inverted upside down and it was decided to perform the revision surgery.(b)(6) 2020: the revision surgery was performed.The insert was found reversed upside down and the tray position was found shifted in "#12" instead of "#6".However, the stem and the tray were firmly interlocked and could not be moved or removed at all, so the stem wasn't removed and the tray was left in the body in the "no.12" position, and only the insert with additional thickness was replaced in the usual orientation.The surgeon commented that he didn't know why only the insert(or only the tray) had rotated without coming off.Since the tray was left in place as it was this time, this patient will need to be monitored for a while to see if the same event occurs again.

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS ASCEND FLEX INSERT
• Type of Device: SHOULDER JOINT POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 10815494
• MDR Text Key: 215464805
• Report Number: 3000931034-2020-00145
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386940507
• UDI-Public: 03700386940507
• Combination Product (y/n): N
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: DIAM. 36MM +6, A-12.5°
• Device Catalogue Number: DWF361B
• Device Lot Number: AC2632
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR