MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS SHOULDER PRESS-FIT STEM DIA.9 130 DG L.115 MM TA6V; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWB712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, the old press fit stem and cortiloc glenoid were revised due to pain in patient.No further patient adverse consequences reported, revision went as planned.
Additional Manufacturer Narrative
Correction: the device was planned to be returned but did not return.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned for investigation.From the provided pictures taken in the operating room just after the devices explantation (soiled humeral stem and head), we can observe that the removed humeral stem has soft tissues/bone attached on its surface.No additional information could be observed.Since operative report, radiology report and extracted implants pictures were provided, the opinion of a medical expert was sought and stated as follows.The operative report, the images and the radiology report of the ct-scan do not reveal a reason (diagnosis) for the postoperative pain.The shown implants are intact and there is no mentioning of any issues of the glenoid component.We cannot determine the reason for the revision, no issues of the implanted devices are mentioned.Please note that the postoperative pain occurred long after the expected lifetime of the device (15 years postoperatively).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 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 old press fit stem, humeral head and cortiloc glenoid were revised due to pain in patient.No further patient adverse consequences reported, revision went as planned.

• Brand Name: AEQUALIS SHOULDER PRESS-FIT STEM DIA.9 130 DG L.115 MM TA6V
• 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: 23477660
• Report Number: 3000931034-2025-00591
• Device Sequence Number: 10227759
• Product Code: KWS
• UDI-Device Identifier: 03700386915734
• UDI-Public: 03700386915734
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K980244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: DWB712
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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: 82 YR
• Patient Sex: Female