MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 4C 137.5DEG 78MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF604C
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
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The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes with the tornier shoulder system.The report details analysis provided for procedures performed between (b)(6)2012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) 2018 a patient required revision surgery due "aseptic loosening humerus|aseptic loosening glenoid", which was not previously reported to the manufacturer.Revision procedure type : "single stage revision¿.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device not returned.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 4C 137.5DEG 78MM
• 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): 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: 16898024
• Report Number: 3000931034-2023-00125
• Device Sequence Number: 12105425
• Product Code: KWS
• UDI-Device Identifier: 03700434019889
• UDI-Public: 03700434019889
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2023

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 Model Number: DWF604C
• Device Catalogue Number: DWF604C
• Device Lot Number: 1355AQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 49 YR
• Patient Sex: Male