MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; REVERSE SHOULDER PROSTHESIS

Model Number	HUMERIS STEM TA6V SIZE 10 CEMENTLESS Ti/HA
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.
Event or Problem Description
This event was a revision surgery due to dislocation approximatively 14 days after primary surgery.Dislocation due to a fall of the patient.The primary surgery used the humeris reversed system.The surgeon explanted the ø40/+3 standard humeral cup and replaced it by the same product.He also explanted the size 10 cementless humeris stem and replaced it by a size 12 cementless humeris stem.

• Brand Name: HUMERIS
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11751478
• Report Number: 3009532798-2021-00047
• Device Sequence Number: 3439096
• Product Code: PHX
• UDI-Device Identifier: 03701037301555
• UDI-Public: 03701037301555
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2021

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: Health Professional
• Device Expiration Date: 10/01/2024
• Device Model Number: HUMERIS STEM TA6V SIZE 10 CEMENTLESS Ti/HA
• Device Catalogue Number: 316-0010
• Device Lot Number: N1558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/30/2021
• 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