MAUDE Adverse Event Report: Tornier S.A.S. TORNIER FLEX SHOULDER SYS REV TRAY 0TH 3.5MM OFFSET; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF520
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	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed due to infection.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Surgical site infections (ssis) are a well-documented and relatively common complication following surgical procedures, with a global incidence of approximately 11% in general surgeries (gillespie, et al., 2021).In trauma surgeries, the risk is often elevated due to factors such as emergency conditions, open fractures, and limited time for optimal preoperative preparation.While it is theoretically possible for an infection to stem from a breach in the sterilization process at the manufacturing site, such occurrences are highly unlikely given the rigorous quality control systems, validated sterilization methods, and multiple checkpoints in place.More commonly, infections may arise from breaches in sterile techniques during handling, storage, or surgery itself¿such as compromised packaging, improper transfer of the implant, or contamination during the procedure.Another main cause of post-operative wound infections (superficial and deep) may be related to post-operative factors, such as the open wound (even when closed with stitches/ staples), wound care/ hygiene, swelling/edema (inflammation), post-operative hematoma, etc.Additionally, patient-related factors, including their own microbiome, represent a significant and often unavoidable source of infection.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 REV TRAY 0TH 3.5MM OFFSET
• 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: 50054850
• Report Number: 3000931034-2026-00589
• Device Sequence Number: 10639856
• Product Code: KWS
• UDI-Device Identifier: 03700434019100
• UDI-Public: (01)03700434019100(11)240509(17)290509
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: DWF520
• Device Lot Number: 7195BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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