MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 6C 137.5DG 86MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	DWF606C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/16/2025
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
Revision shoulder replacement.Anatomic replacement removed as part of two stage revision procedure.3 implants removed.Primary surgery took place in 2021.Glenoid component was loose causing the need for revision surgery for unknown cause, surgeon testing for infecting.Humeral components were stable but everything was removed to clear infection.
Additional Manufacturer Narrative
The reported event could not be confirmed as the device was not returned for evaluation.A device inspection was not possible since the affected devices were not returned.Photos of explanted devices are not sufficient to carry out product inspections.No defect could be noticed on the devices.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.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 further information is provided the complaint report will be updated.
Event or Problem Description
Revision shoulder replacement.Anatomic replacement removed as part of two stage revision procedure.3 implants removed.Primary surgery took place in 2021.Glenoid component was loose causing the need for revision surgery for unknown cause, surgeon testing for infecting.Humeral components were stable but everything was removed to clear infection.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 6C 137.5DG 86MM
• 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: 22026794
• Report Number: 3000931034-2025-00240
• Device Sequence Number: 7238109
• Product Code: KWS
• UDI-Device Identifier: 03700434019261
• UDI-Public: (01)03700434019261(17)211221(10)9455AR021
• 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 Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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 Expiration Date: 12/26/2021
• Device Catalogue Number: DWF606C
• Device Lot Number: 9455AR21
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2016
• 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: 69 YR
• Patient Sex: Male