MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV TRAY 12TH 1.5MM OFFSET; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF512
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Joint Dislocation (2374)
Date of Event	11/16/2025
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
Patient endured dislocation of the shoulder, closed reduction with sedation was utilized to reset the joint.
Event or Problem Description
Patient endured dislocation of the shoulder, closed reduction with sedation was utilized to reset the joint.
Additional Manufacturer Narrative
The reported event could be confirmed based on the available medical records and formal medical expert opinion.A formal medical opinion was sought which revealed: " baseplate fixation in reverse total shoulder arthroplasty is influenced by multiple factors, including implant sizing and positioning, bone quality, peripheral screw fixation, and osseointegration.Selection of a short post versus a central screw is only one component and does not independently determine joint stability.The patient¿s early postoperative dislocations (2¿4 months) cannot be attributed to a single cause without clinical examination.Shoulder instability after reverse arthroplasty is typically multifactorial, involving patient related, biomechanical, and surgical factors.Review of radiographic reports demonstrates appropriate implant positioning with no evidence of malposition, migration, disengagement, impingement, or fracture.Insertion of a thicker polyethylene tray during revision surgery is commonly intended to improve stability by increasing soft tissue tension and joint compression.However, this measure alone is unlikely to resolve instability if other contributing factors remain unaddressed.¿ a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labelling did not indicate any abnormalities.Based on the available information, root cause could not be established.There is no indication of device related failure.Potential contributing factors may include component malposition (such as glenosphere or humeral alignment), inadequate soft tissue balancing, subscapularis insufficiency, bone loss, or patient specific factors including neuromuscular control.As stryker is not the treating physician, a direct clinical assessment of the patient¿s shoulder is not possible.If any further information is provided the complaint report will be updated.

• Brand Name: TORNIER FLEX SHOULDER SYS REV TRAY 12TH 1.5MM 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 ; 2018315000
• MDR Report Key: 24517872
• Report Number: 3000931034-2026-00240
• Device Sequence Number: 15582144
• Product Code: KWS
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: DWF512
• Device Lot Number: 6660AZ
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2023
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 200 LB