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

Model Number SIZE 4C ANGLE 137.5° PTC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Pain (1994); Osteolysis (2377)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent a revision surgery due to potential glenoid erosion leading to glenohumeral arthritis.(b)(6).

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 STEM
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 11130566
• MDR Text Key: 225488663
• Report Number: 3000931034-2021-00003
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386944581
• UDI-Public: 03700386944581
• Combination Product (y/n): N
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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: SIZE 4C ANGLE 137.5° PTC
• Device Catalogue Number: DWF604C
• Device Lot Number: 7235AN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR