MAUDE Adverse Event Report: Tornier S.A.S. AEQ FRACTURE HUMERAL STEM DIA9 MM LENGTH 130MM COATING HAP; prosthesis, shoulder, semi-constrained, metal/polymer cemented

Catalog Number	DWB172
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and, if received, will be provided in a supplemental report.
Event or Problem Description
The stem was removed due to an infection.The patient has been monitored using a cement mold.

• Brand Name: AEQ FRACTURE HUMERAL STEM DIA9 MM LENGTH 130MM COATING HAP
• 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 ; +1(201)831-5000
• MDR Report Key: 25536367
• Report Number: 3000931034-2026-00511
• Device Sequence Number: 9634076
• Product Code: KWS
• UDI-Device Identifier: 03700386915369
• UDI-Public: 03700386915369
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: DWB172
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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: Unknown