MAUDE Adverse Event Report: Tornier S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 42MM 6TH B 12.5DG; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Catalog Number	DWF421B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "revision surgery due to infection.Primary surgery completed (b)(6)2024.All implants removed today due to infection.Wash out was attempted two weeks prior but failed.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 42MM 6TH B 12.5DG
• 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: 50193691
• Report Number: 3000931034-2026-00639
• Device Sequence Number: 6111055
• Product Code: KWS
• UDI-Device Identifier: 03700434021516
• UDI-Public: 03700434021516
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: DWF421B
• Device Lot Number: AG7313018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/10/2026
• 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