MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 36MM 9TH B 12.5DG; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	DWF365B
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Implant Pain (4561)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "subject: (b)(6) shout - tornier shoulder outcomes study: subject noticed a sudden increase in pain on (b)(6) 2021, yet did not suffer any accident, incident, or fall.Follow up x-rays on (b)(6) 2021 revealed an anterior superior reverse shoulder dislocation.The humeral components were still stable and there was a hint of bone bridging from the native upper humerus to the native lower humerus across the allograft.Revision surgery on (b)(6) 2021".
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.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A device inspection was not possible since the affected device was not returned for investigation.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 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
As reported: "subject: (b)(6) shout - tornier shoulder outcomes study.Subject noticed a sudden increase in pain on (b)(6) 2021, yet did not suffer any accident, incident, or fall.Follow up x-rays on (b)(6) 2021 revealed an anterior superior reverse shoulder dislocation.The humeral components were still stable and there was a hint of bone bridging from the native upper humerus to the native lower humerus across the allograft.Revision surgery on (b)(6) 2021".

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 36MM 9TH B 12.5DG
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21035638
• Report Number: 3000931034-2024-00699
• Device Sequence Number: 7655956
• Product Code: KWS
• UDI-Device Identifier: 03700434022582
• UDI-Public: 03700434022582
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/27/2023
• Device Catalogue Number: DWF365B
• Device Lot Number: AB7569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2018
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 61 KG