MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED 4.5MM LOCKING SCREW 20MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWD020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed to convert from reverse shoulder to hemi due to glenoid component baseplate failure and scapular fracture.The glenoid baseplate/implants became loose following initial surgery.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
Corrections: please refer to h6 results code the reported event could be confirmed.The device was not returned but evidences were provided, which match the alleged failure.A device inspection was not possible since the affected device was not returned for investigation.Since data and images were provided, the opinion of a medical expert was sought and stated as follows: the scapular fracture is a periprosthetic fracture of the glenoid bone which gave the implant the freedom to move upwards.The image shows the upward moving of the glenoid implant and the glenoid (scapular) periprosthetic fracture.If there was no trauma, poor bone quality is the most likely cause of this event.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
A revision surgery was performed to convert from reverse shoulder to hemi due to glenoid component baseplate failure and scapular fracture.The glenoid baseplate/implants became loose following initial surgery.

• Brand Name: AEQUALIS REVERSED 4.5MM LOCKING SCREW 20MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 23117890
• Report Number: 3000931034-2025-00504
• Device Sequence Number: 18079862
• Product Code: KWS
• UDI-Device Identifier: 03700386916625
• UDI-Public: 03700386916625
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: DWD020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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: 73 YR
• Patient Sex: Female