MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERSED; REVERSED SHOULDER PROSTHESIS

Model Number	DIAMETER 36 mm ECCENTRIC
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number 3014128390-2021-00016.
Event or Problem Description
Patient revised for third time due to non-compliance with post-surgical instructions on (b)(6) 2021, approximately 5 weeks after primary surgery.First two revisions previously reported.Surgeon explanted 36mm eccentric glenosphere with screw, 36/+9 stability humeral cup, and humelock reversed 36/14 cementless lockable stem.He then implanted a 40mm eccentric glenosphere with screw and humeral side components from another manufacturer, which is an off-label use of the fx shoulder device.

• Brand Name: HUMELOCK REVERSED
• Common Device Name: REVERSED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11796988
• Report Number: 3009532798-2021-00058
• Device Sequence Number: 14346524
• Product Code: PHX
• UDI-Device Identifier: 03701037300275
• UDI-Public: 03701037300275
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150488
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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: 02/01/2024
• Device Model Number: DIAMETER 36 mm ECCENTRIC
• Device Catalogue Number: 105-3613
• Device Lot Number: M3771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 05/10/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR