MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYSTEM HEAD LOW OFFSET 48MMX18MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF048
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/21/2025
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
It was reported that, the revision surgery of tornier anatomic shoulder from 2016.Glenoid loosened as this was dominant arm and patient used a walking stick the entire time.Procedure was to revise to a reverse, however.Intraop glenoid fracture occurred and so a new cobalt chrome head was put on the existing stem and no glenoid component.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned for investigation.From the provided pictures taken in the operating room just after each devices explantation (soiled explants), no additional information could be observed.Since data, x-rays and pictures of the extracted implants were provided, the opinion of a medical expert was sought and stated as follows the available imaging does not confirm any of the events mentioned (anatomic glenoid loosening or glenoid fracture during revision).The image quality of the fluoroscopy photos that were taken of a computer screen do not allow for detailed medical grade assessment of the images.The image of the intraoperatively explanted glenoid baseplate does not show the status of the glenoid.We can only rely on the trustworthiness of the written information by the sales rep.Due to a lack of information we cannot determine the root cause.All implant components look intact on the images.Most likely patient related factors are in play.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that, the revision surgery of tornier anatomic shoulder from 2016.Glenoid loosened as this was dominant arm and patient used a walking stick the entire time.Procedure was to revise to a reverse however intraop glenoid fracture occurred and so a new cobalt chrome head was put on the existing stem and no glenoid component.

• Brand Name: TORNIER FLEX SHOULDER SYSTEM HEAD LOW OFFSET 48MMX18MM
• 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: 23602515
• Report Number: 3000931034-2025-00607
• Device Sequence Number: 15753959
• Product Code: KWS
• UDI-Device Identifier: 03700434021745
• UDI-Public: 03700434021745
• 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: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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 Expiration Date: 10/01/2019
• Device Catalogue Number: DWF048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2014
• 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: 78 YR
• Patient Sex: Female