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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, originally revision surgery cancelled due to unknown reasons.It was rebooked for (b)(6)2026.Surgeon had planned to revise glenoid due to glenoid loosening during a recent fall.During case, surgeon identified that arthroplasty joint had been infected in his opinion.All humeral and glenoid components were removed without difficulty.Multiple tissue samples were taken.Debridement and copious lavage was performed.Antibiotic cement spacer was implanted for a two stage revision.Dr (b)(6) stated that there were no clinical markers indicative of joint infection.Second stage revision planned for 2-3 months.No further x-ray & ct available no pathology report available no other patient details available.Second stage procedure using competitor product.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the 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 ; +1(201)831-5000
• MDR Report Key: 50122403
• Report Number: 3000931034-2026-00599
• Device Sequence Number: 10560391
• Product Code: KWS
• UDI-Device Identifier: 03700434022148
• UDI-Public: 03700434022148
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 3201AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2022
• 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