MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 42MM X 29MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWD193
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "subject: (b)(6).Shout - tornier shoulder outcomes study.Considerable ongoing left shoulder pain and increasing left axillary pain.No injury.On (b)(6) 2021, subject first reported considerable left shoulder pain.X-rays and physical exam were normal without any evidence of complication.He was instructed to return in 1 year for annual follow up.On (b)(6) 2022, he repeated these complaints.Yet again, x-rays did not reveal evidence of loosening.Surgeon attempted aspiration to send for culture but was unable to obtain any fluid.Subject was sent for cbc, esr, and crp labs.Surgeon thought infection was unlikely but wanted to investigate all potential causes for ongoing pain.On (b)(6) 2022, subject returned with continued complaints of pain, especially around the pectoralis insertion and to a lesser degree in the back of the shoulder.He complained of some mechanical symptoms especially at nighttime, when he is positioned in bed, and with motion.Inflammatory lab workup was negative.Dr.(b)(6) suggested ct scan to rule out mechanical complications.On (b)(6) 2022, subject returned for ct review, which did not show any mechanical complications.Surgeon stated that the implants looked good with no loosening or component fracture.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE CENTERED 42MM X 29MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21122535
• Report Number: 3000931034-2025-00025
• Device Sequence Number: 8733016
• Product Code: PHX
• UDI-Device Identifier: 03700386935916
• UDI-Public: 03700386935916
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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 Catalogue Number: DWD193
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 83 KG