MAUDE Adverse Event Report: TORNIER S.A.S. AEQ REVSD FRACTURE LATERALIZED HMRL INSERT DIA42MM THCK +9MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWD967
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the revision surgery was performed wherein the exchange of poly liner on aequalis reverse fracture stem was done.Lateralised 9mm 42 liner removed.Replaced with a 9mm spacer and 6mm retentive 42 liner.Patient has a 42 lateralised sphere insitu.It was reported that, he had recurrent dislocations due to his behaviour- alcoholic and non-compliant.
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 be confirmed.However, since the device was not returned for evaluation, the confirmation is based on the medical expert opinion.The device inspection revealed the following.Visual examination of the device, based on the provided images, indicated that the polyethylene component was soaked in blood and exhibited damage to its threading.Moreover, as per medical expert opinion, based on the provided x-ray, the implants appear well-fixed.The recurrent dislocations are most likely patient-related and have led to polyethylene liner damage, reducing conformity with the glenosphere and increasing the likelihood of further dislocations.The images indicate a post-fracture indication, supporting that patient-related factors are the most probable cause.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a patient related issue.Most likely, the event was caused due to patient behavior.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that, the revision surgery was performed wherein the exchange of poly liner on aequalis reverse fracture stem was done.Lateralised 9mm 42 liner removed.Replaced with a 9mm spacer and 6mm retentive 42 liner.Patient has a 42 lateralised sphere insitu.It was reported that, he had recurrent dislocations due to his behaviour- alcoholic and non compliant.

• Brand Name: AEQ REVSD FRACTURE LATERALIZED HMRL INSERT DIA42MM THCK +9MM
• 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: 23649267
• Report Number: 3000931034-2025-00623
• Device Sequence Number: 11968198
• Product Code: PHX
• UDI-Device Identifier: 03700386936364
• UDI-Public: (01)03700386936364(11)230405(17)280405(21)9975AY030
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWD967
• Device Lot Number: 9975AY
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/06/2026
• 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 Sex: Male