MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 39MM 9TH C 7.5DG; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	DWF392C
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device is retained by hospital or patient.
Event or Problem Description
As reported: "patient required revision surgery due to the device dislocating.
Additional Manufacturer Narrative
Please note correction to d3 (manufacturer entity).The reported event could be confirmed, since the x-rays and data were provided.A device inspection was not possible since the affected device was not returned.The opinion of the medical expert was requested and stated as following: "with the available information i may interpret the description of the event as a patient not being fully compliant to the surgeons¿ instruction regarding the use of the immobilizer." we can consider the event as confirmed, in such a way that the revision surgery and component exchanges are documented.The x-rays do not show a dislocation of the rtsa, so we do not have direct proof.It is however very likely that instability was the indication for this typical component exchange (humeral reversed tray, polyethylene insert, and glenosphere), leaving the humeral stem and baseplate/screws in place.Based on investigation, the root cause was attributed to a patient user related issue.The event was caused by a rehabilitation recommendation was not followed regarding the use of the immobilizer.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "patient required revision surgery due to the device dislocating.'.

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 39MM 9TH C 7.5DG
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; postfach; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17813879
• Report Number: 3000931034-2023-00322
• Device Sequence Number: 7380139
• Product Code: HSD
• UDI-Device Identifier: 03700434020663
• UDI-Public: 03700434020663
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: 04/11/2024
• Device Catalogue Number: DWF392C
• Device Lot Number: 6962AU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2019
• 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: 76 YR
• Patient Sex: Male