MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV TRAY 0TH 1.5MM OFFSET; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF510
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient previously underwent a left reverse shoulder replacement following a fracture of the left proximal humeral head.In recent months, the patient experienced shoulder instability, recurrent dislocations, and pain.During the revision procedure, the prosthetic shoulder joint was found to be easily dislocated with gross soft tissue laxity.All implanted components were well fixed, and no polyethylene wear was observed.The flex reversed tray, flex reversed insert, and perform reversed glenoid standard glenosphere were removed and replaced with a perform reversed 36 mm eccentric glenosphere, low offset +0 mm reversed tray, and 36 mm/6 mm retentive b angle polyethylene insert.All remaining implants were left in place.Following implantation of the new components, the shoulder was reduced successfully and was stable throughout the full range of motion.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.

• Brand Name: TORNIER FLEX SHOULDER SYS REV TRAY 0TH 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: 25738517
• Report Number: 3000931034-2026-00565
• Device Sequence Number: 18731591
• Product Code: KWS
• UDI-Device Identifier: 03700434022148
• UDI-Public: 03700434022148
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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: DWF510
• Device Lot Number: 8982BB031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 07/07/2026
• 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: 74 YR
• Patient Sex: Female