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	Migration (4003)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Joint Impingement (4834)
Date of Event	04/17/2025
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 underwent right reverse shoulder replacement on (b)(6) 2025.Over recent weeks, patient has dislocated their prosthetic shoulder joint twice, during abduction and external rotation.Patient underwent shoulder ct, and reviewed by surgeon, who suspected some boney or soft tissue impingement was causing the joint instability, though ct looked unremarkable.During surgery there were some boney projections on the posterior humeral head found, & subsequently removed, plus some excess posterior capsule, also removed.Joint laxity also noted.The primary poly ,offset tray removed; primary implanted perform reverse glenosphere removed, and replaced by eccentric glenosphere.Surgeon also implanted a tray and pol.Joint was found to be stable, full range of motion demonstrated without dislocation.Wound closed.
Additional Manufacturer Narrative
Correction - please refer h6 conclusion code.The reported event could be confirmed, based on assessment of available information by medical expert.A device inspection was not possible since the affected device was not returned and no other evidences were provided 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.Upon further assessment of provided information and ct scans hcp opined that the unremarkable ct-scan does not show any signs of joint instability.The implants are intact and well-positioned.The adverse event is not a device related issue, might be patient-related and surgical technique related.I have no reasons to believe that the surgeon's assessment was incorrect.Based on investigation, the root cause was attributed most likely to a patient related issue.The failure was likely caused due to boney projections in the proximal humeral head.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Patient underwent right reverse shoulder replacement on (b)(6) 2025.Over recent weeks, patient has dislocated their prosthetic shoulder joint twice, during abduction and external rotation.Patient underwent shoulder ct, and reviewed by surgeon, who suspected some boney or soft tissue impingement was causing the joint instability, though ct looked unremarkable.During surgery there were some boney projections on the posterior humeral head found, & subsequently removed, plus some excess posterior capsule, also removed.Joint laxity also noted.The primary poly offset tray removed; primary implanted perform reverse glenosphere removed and replaced by eccentric glenosphere.Surgeon also implanted a tray and pol.Joint was found to be stable, full range of motion demonstrated without dislocation.Wound closed.

• 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 ; 2018315000
• MDR Report Key: 22028023
• Report Number: 3000931034-2025-00246
• Device Sequence Number: 12797427
• Product Code: KWS
• UDI-Device Identifier: 03700434019100
• UDI-Public: (01)03700434019100(11)240811(17)290811(10)0576BB035
• 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): 09/02/2025

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: DWF520
• Device Lot Number: 0576BB035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2024
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 90 KG