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

Model Number DIAMETER 36 mm CENTERED

Device Problems Disconnection (1171); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient revised on (b)(6) 2021 due to glenosphere disassociation approximately 2 years after primary surgery.Surgeon explanted the 36mm centered glenosphere with screw and 135/145 36/+3 standard humeral cup, and then implanted a new 36mm centered glenosphere with screw and 135/145 36/+9 stability humeral cup.

• Brand Name: HUMERIS
• 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: 11796990
• MDR Text Key: 249699930
• Report Number: 3009532798-2021-00051
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300268
• UDI-Public: 03701037300268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: DIAMETER 36 mm CENTERED
• Device Catalogue Number: 105-3610
• Device Lot Number: M1319
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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; Required Intervention
• Patient Age: 77 YR