MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 36MM 6TH B 12.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF361B
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	12/09/2025
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 patient had a revision for a bio-rsa glenoid patient which had appeared to have a re-absorbed.The surgeon removed the glenosphere and baseplate with ease from the glenoid socket and packed it full with femoral head allograft.The tray and poly were removed from the flex stem and surgeon placed a 50x16 cocr flex humeral head onto the stem to turn it to a hemi.It was reported in a final report from surgeon, the right shoulder prosthesis was dislocated with the humeral end lying inferior to the glenoid prosthetic margin.Extensive osteolysis surrounding the glenoid component.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned, but evidence was provided, which matches the alleged failure.A device inspection was not possible since the affected device was not returned.From the provided picture taken just after the devices explantation, we can observe the presence of soft tissues on the removed implants and the received plastic insert had a half-worn area on the functional flat surface, probably due to the friction with the glenoid components.No additional information could be observed.Since data, a pre-op x-ray, blueprint images, and a picture of the extracted implants were provided, the opinion of a medical expert was sought and stated as follows regarding the dislocation issue, the humerus together with the humeral implant has dislocated in the glenohumeral articulation.The humeral stem is well-fixed to the bone and the humeral tray is well fixed to the stem.Regarding the reported osteolysis surrounding the glenoid component the direction of the x-ray does not allow for a detailed assessment of bone surrounding the glenoid baseplate.The baseplate is however, angled superiorly which can be related to implant migration.Since we have no earlier images to compare with, a detailed assessment is not possible.Since the surgeon needed to fill the glenoid defect with a femoral bone graft, we may assume bone loss due to osteolysis on the glenoid side patient related most likely, resorption of bio-rsa bone graft followed by loosening of the glenoid baseplate.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.Resorption of the bio-rsa bone graft, followed by loosening of the glenoid baseplate, is the most likely root cause of the glenohumeral dislocation observed.However, more detailed information about the complaint event must be available in order to clearly determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that, the patient had a revision for a bio-rsa glenoid patient which had appeared to have a re-absorbed.The surgeon removed the glenosphere and baseplate with ease from the glenoid socket and packed it full with femoral head allograft.The tray and poly were removed from the flex stem and surgeon placed a 50x16 cocr flex humeral head onto the stem to turn it to a hemi.It was reported in a final report from surgeon, the right shoulder prosthesis was dislocated with the humeral end lying inferior to the glenoid prosthetic margin.Extensive osteolysis surrounding the glenoid component.No further information was provided.

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 36MM 6TH B 12.5DG
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23976685
• Report Number: 3000931034-2026-00030
• Device Sequence Number: 10621458
• Product Code: KWS
• UDI-Device Identifier: 03700434020861
• UDI-Public: (01)03700434020861(11)230502(17)280502(21)AF7815015
• 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: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWF361B
• Device Lot Number: AF7815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2023
• 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: 64 YR
• Patient Sex: Female