MAUDE Adverse Event Report: Tornier S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 36MM 6TH B 12.5DG; prosthesis, shoulder, semi-constrained, metal/polymer cemented

Catalog Number	DWF361B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that a revision of a reverse shoulder replacement was performed.The previously implanted devices, including the dwj012, dwf714b, dwf510, and dwf361b, were explanted and replaced with new devices, including the dwj012, dwf362b, dwf712b, and dwf510.The reason for the revision was not provided.

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 36MM 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 Inc; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25347925
• Report Number: 3000931034-2026-00480
• Device Sequence Number: 10668791
• Product Code: KWS
• UDI-Device Identifier: 03700434021363
• UDI-Public: 03700434021363
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: DWF361B
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 09/18/2026
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 116 LB