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

Model Number 115-3610

Device Problems Material Separation (1562); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number (b)(4).

Event Description

The patient was revised on (b)(6) 2022 for dismantling.Approximately 3 months after the first surgery.The surgeon explanted 1 humeral cup (36/6) and 1 centered glenosphere (36).The surgeon implanted 1 humeral cup (40/6) and 1 centered glenosphere (40).

• Brand Name: HUMERIS REVERSED
• Type of Device: REVERSED SHOULDER PROSTHESIS
• 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: ratsamy thevenin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 13657909
• MDR Text Key: 286493828
• Report Number: 3009532798-2022-00034
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300800
• UDI-Public: 03701037300800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/08/2022

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
• Device Model Number: 115-3610
• Device Catalogue Number: 115-3610
• Device Lot Number: S0187
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization