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

Model Number	36MM ; +6 ; A-12.5°
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
(b)(6) 2020: ascend flex reverse surgery was performed.Lately in (b)(6) ,2020: signs of infection were found after the surgery.(b)(6) 2021: revision surgery was performed.All the implants were removed, the affected part was cleaned, the spacer made by cement was implanted, and the surgery was completed.

• 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: 12142357
• Report Number: 3000931034-2021-00047
• Device Sequence Number: 3989096
• Product Code: KWS
• UDI-Device Identifier: 03700386940507
• UDI-Public: 03700386940507
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: Lay User/Patient
• Device Expiration Date: 06/12/2025
• Device Model Number: 36MM ; +6 ; A-12.5°
• Device Catalogue Number: DWF361B
• Device Lot Number: AD1238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 07/09/2021
• 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
• Patient Age: 82 YR