MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS SPHERICAL BASE GLENOID LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWB003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.The report details analysis provided for revision procedures performed until (b)(6) 2025.During the review of the report, it was identified that on (b)(6) 2024 a patient required revision surgery due to infection, which was not previously reported to the manufacturer.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device(s) were not returned for evaluation, and no other additional information was received from the clinical site.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
Additional Manufacturer Narrative
Correction made to fields d3: manufacturer entity and g1: manufacturing site for devices.
Event or Problem Description
The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.The report details analysis provided for revision procedures performed until (b)(6) 2025.During the review of the report, it was identified that on (b)(6) 2024 a patient required revision surgery due to infection, which was not previously reported to the manufacturer.

• Brand Name: AEQUALIS SPHERICAL BASE GLENOID LARGE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21771797
• Report Number: 3000931034-2025-00162
• Device Sequence Number: 10161865
• Product Code: KWS
• UDI-Device Identifier: 03700386915086
• UDI-Public: 03700386915086
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K994392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: DWB003
• Device Lot Number: 2705AM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/04/2025
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG