MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 44 STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWD144
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the revision surgery was performed and the ascend flex/reversed ii implants were revised to the perform reverse glenoid implants as the glenoid implants had migrated superiorly.Revision surgery was successfully completed.It was further reported that, all glenoid implants were removed (suspects), the humeral tray and liner was removed (concomitants).Humeral stem remained stable and so surgeon left in situ.New tray and liner and glenoid system inserted successfully.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned for investigation.From the provided pictures taken just after the devices explantation (soiled implants), only the insert and the tray were taken in photos.The plastic insert was damaged on one side, probably due to the glenoid side migration that rubbed against the humeral side.No additional information could be observed.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that, the revision surgery was performed and the ascend flex/reversed ii implants were revised to the perform reverse glenoid implants as the glenoid implants had migrated superiorly.Revision surgery was successfully completed.It was further reported that, all glenoid implants were removed (suspects), the humeral tray and liner was removed (concomitants).Humeral stem remained stable and so surgeon left in situ.New tray and liner and glenoid system inserted successfully.

• Brand Name: AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 44 STERILE
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23405215
• Report Number: 3000931034-2025-00585
• Device Sequence Number: 4929713
• Product Code: PHX
• UDI-Device Identifier: 00846832092147
• UDI-Public: 00846832092147
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWD144
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/05/2026
• 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: 67 YR
• Patient Sex: Male