MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 42MM 6TH B 12.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF421B
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Inflammation (1932); Joint Dislocation (2374)
Date of Event	06/26/2024
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.
Event or Problem Description
Flex revive study.Patient: (b)(6).As reported: revision surgery performed on (b)(6) 2024.Due to post-operative complication: instability/dislocation.Adverse event in details : "called on 04 jun 24, dislocated on (b)(6) 2024.Subsequent recurrent dislocation.Scheduled for revision on (b)(6) 2024." treatment/ medication: yes.Medication: over the counter anti-inflammatory.Other action taken: yes, sling and revision surgery on (b)(6) 2024.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product 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.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 device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
Flex revive study patient: (b)(6).As reported: revision surgery performed on (b)(6) 2024.Due to post-operative complication: instability/dislocation.Adverse event in details : "called on (b)(6) 2024, dislocated on (b)(6) 2024.Subsequent recurrent dislocation.Scheduled for revision on (b)(6) 2024." treatment/ medication: yes.Medication: over the counter anti-inflammatory.Other action taken: yes, sling and revision surgery on (b)(6) 2024.

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 42MM 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): 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: 19833881
• Report Number: 3000931034-2024-00393
• Device Sequence Number: 7666193
• Product Code: KWS
• UDI-Device Identifier: 03700434021516
• UDI-Public: 03700434021516
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWF421B
• Device Lot Number: AD9886
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2021
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 100 KG