MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; REVERSED SHOULDER PROTHESIS

Catalog Number	112-0100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is a remediation for an event that happened in the usa on (b)(6) 2023 and for which we couldn't find any proof of transmission from the person in charge of reporting at the time.
Event or Problem Description
The patient was revised due to dislocation on (b)(6) 2023.The implantation date was on (b)(6)2019.A cup and a reversed adapter were explanted.No element were implanted.

• Brand Name: HUMERIS
• Common Device Name: REVERSED SHOULDER PROTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: emeric obin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 18160043
• Report Number: 3009532798-2023-00108
• Device Sequence Number: 12578892
• Product Code: PHX
• UDI-Device Identifier: 03701037300770
• UDI-Public: 03701037300770
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

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: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 112-0100
• Device Lot Number: M1892
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown