MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 39MM 9TH B 12.5DG R; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	DWF395B
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
Patient has continued to experience laxity, occasional dislocations of her affected shoulder joint, including pain, poor range of motion.Surgeon decided during surgery to again increase glenosphere diameter and increase humeral reverse tray , and again implant a retentive poly insert.Prosthesis implanted, shoulder joint reduced and found to be stable through range of motion.
Event or Problem Description
Patient has continued to experience laxity, occasional dislocations of her affected shoulder joint, including pain, poor range of motion.Surgeon decided during surgery to again increase glenosphere diameter and increase humeral reverse tray , and again implant a retentive poly insert.Prosthesis implanted, shoulder joint reduced and found to be stable through range of motion.
Additional Manufacturer Narrative
Correction - please refer h6 device code and method code.The reported event could not be confirmed based on the evaluation done by the hcp on provided xray image.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.No indications of material manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.However on the available xray medical opinion was sought from an experienced independent medical expert as below the implants are well fixed to the bone and well-positioned.The surgeon did a good job to provide a stable glenohumeral joint.Laxity is a matter of soft tissue tension.In some patient adequate soft tissue tension is difficult to achieve hence the root cause is attributed to a patient related issue.If device is returned or any further information is provided the investigation report will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 39MM 9TH B 12.5DG R
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21632342
• Report Number: 3000931034-2025-00137
• Device Sequence Number: 15337438
• Product Code: KWS
• UDI-Device Identifier: 03700386940804
• UDI-Public: (01)03700386940804(11)211027(17)261027(21)1952AX003
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: DWF395B
• Device Lot Number: 1952AX
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2021
• 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