MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 42MM 9TH B 12.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF422B
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that there was a third revision shoulder replacement surgery performed on a patient with recurrent dislocations.This was the fourth surgery on the same shoulder.All humeral components (stem, tray, poly) were removed and replaced: a 2b standard stem was replaced with a 3c standard stem, a high offset +6 tray was replaced with a high offset +12 tray, and a flex reversed insert b +9 was replaced with a flex reversed insert b +9 retentive.The glenoid implants were left intact.
Event or Problem Description
It was reported that there was a third revision shoulder replacement surgery performed on a patient with recurrent dislocations.This was the fourth surgery on the same shoulder.All humeral components (stem, tray, poly) were removed and replaced: a 2b standard stem was replaced with a 3c standard stem, a high offset +6 tray was replaced with a high offset +12 tray, and a flex reversed insert b +9 was replaced with a flex reversed insert b +9 retentive.The glenoid implants were left intact.
Additional Manufacturer Narrative
Correction: h6 device code.H6 health impact code.The reported event was confirmed.The device was not returned but evidences were provided, based on provided images and reported data, which match the alleged failure.A device inspection was not possible since the affected device was not returned for investigation.On the provided x-rays taken prior to last surgery, the shoulder dislocation is confirmed.The glenoid side is completely out of the humeral side.Since images and data were provided, the opinion of the medical expert was requested and stated, as follows: with the information at hand, we can see that the surgeon stepwise increased humeral off-set and distalization to improve the soft tissue tension to increase the stability of the shoulder arthroplasty.Interestingly the surgeon addressed the issue 3 times from the humeral side.The glenoid side is of interest as well although, unfortunately, the x-ray quality is not sufficient to assess the glenoid position precisely enough.Yet it looks placed a bit neutral or even facing a bit superiorly.That could be a factor in the lack of stability as well.The last image showed a dislocated but intact and well-fixed device.Recurrent dislocation due to lack of soft-tissue stability is for sure patient related, and additional x-rays/ct scan may confirm or exclude the impression that the glenoid is tilted a bit superiorly.With the available information i can conclude to a patient-related issue.Based on investigation, the root cause of this event is attributed to a patient-related issue (patient's lack of stability in the soft tissue).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 more information is provided, the case will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 42MM 9TH 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): 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: 19671045
• Report Number: 3000931034-2024-00357
• Device Sequence Number: 11566184
• Product Code: KWS
• UDI-Device Identifier: 03700434019001
• UDI-Public: 03700434019001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: DWF422B
• Device Lot Number: AE1677
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2022
• 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: 74 YR
• Patient Sex: Male