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 Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Post Operative Wound Infection (2446); Inadequate Osseointegration (2646)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed due to humeral stem loosening caused by a suspected chronic infection as well as dislocation.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
A revision surgery was performed due to humeral stem loosening caused by a suspected chronic infection as well as dislocation.
Additional Manufacturer Narrative
Correction: h6 (device) code.\ \ 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.\ \ the opinion of the medical expert was requested on this case despite the limited information provided, and stated as following:\ \"there is no dislocation of the glenohumeral reverse articulation.The humeral tray and the glenosphere are well-aligned.\ the image quality is not sufficient to diagnose humeral stem loosening with certainty.There is some humeral bone loss proximally but it is not a lot.\ an infection is unlikely because especially in chronic cases that would also affect the glenoid side, which it did not in this case.\ the glenoid side looks good.Components well-fixed, in a good position.Good fixation of the baseplate was confirmed during revision surgery.\ we cannot confirm from the available images, we would need to see the x-rays and have more clinical information\".\ \ 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.

• 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 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: 25049780
• Report Number: 3000931034-2026-00390
• Device Sequence Number: 18744709
• Product Code: KWS
• UDI-Device Identifier: 03700434020861
• UDI-Public: 03700434020861
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: DWF361B
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 07/13/2026
• 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: 76 YR
• Patient Sex: Unknown