MAUDE Adverse Event Report: TORNIER S.A.S. FLEX SHOULDER SYSTEM REVERSED TRAY DIA. 40 TH 0 ECC 3.5; SHOULDER JOINT METAL PROSTHESIS

Model Number	DIAMETER 40MM TH 0 ECC 3.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Patient was revised on (b)(6) 2021 due to instability post reverse total shoulder replacement (tornier threaded post baseplate, screws, glenosphere, tray and insert removed by the surgeon in durango co).Tornier flex ptc 6b long stem was reported well fixed by the surgeon, so retained in patient.The patient was compliant to mobilization instructions of the surgeon but not the long term weight restrictions.The surgeon did not want to provide the ct scans.The patient was pulling hoses 9 months post op and felt a "pop" that was presumably a dislocation he states, multiple self reported dislocations, none documented until late winter early of 2021.The surgeon wants to make sure it¿s clearly understood that he has no complaint against our products, just reporting as asked of a revision total shoulder.Reversed insert were implanted.

• Brand Name: FLEX SHOULDER SYSTEM REVERSED TRAY DIA. 40 TH 0 ECC 3.5
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• MDR Report Key: 11866460
• Report Number: 3000931034-2021-00254
• Device Sequence Number: 19925261
• Product Code: KWS
• UDI-Device Identifier: 03700386941078
• UDI-Public: 03700386941078
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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: 08/07/2024
• Device Model Number: DIAMETER 40MM TH 0 ECC 3.5
• Device Catalogue Number: DWF520
• Device Lot Number: 0569AV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR