MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 39MM 6TH B 12.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF391B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event of a patient requiring revision surgery due to infection could not be confirmed, since the device was not returned for evaluation and no other additional information will be made available by the national joint registry.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Please note, that reports received from the national joint registry are not published reports and therefore web link is not available.
Event or Problem Description
The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes with the tornier shoulder system.The report details analysis provided for procedures performed between (b)(6) 2012 ¿ (b)(6) 2022.During the review of the report, it was identified that on (b)(6) 2022 a patient required revision surgery due to infection, which was not previously reported to the manufacturer.Revision procedure type: stage 1 of 2 stage revision.

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 39MM 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: 20180297
• Report Number: 3000931034-2024-00542
• Device Sequence Number: 8261389
• Product Code: KWS
• UDI-Device Identifier: 03700434021066
• UDI-Public: 03700434021066
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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 Expiration Date: 07/08/2026
• Device Catalogue Number: DWF391B
• Device Lot Number: 8268AW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2021
• 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: 60 YR
• Patient Sex: Male