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

Model Number 109-4525

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2021

Event Type  Injury  

Event Description

The patient was revised on (b)(6) 2021, approximately 07 months after the primary surgery on (b)(6) 2021 due to patient non-compliance.The patient is an alcoholic and had a fall which required a revision.The humeral cup (36/3) was explanted and a humeral cup (36/9) was implanted.

Manufacturer Narrative

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

• Brand Name: HUMELOCK 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: 13384993
• MDR Text Key: 284675521
• Report Number: 3009532798-2021-00243
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037302224
• UDI-Public: 03701037302224
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 109-4525
• Device Catalogue Number: 109-4525
• Device Lot Number: S0022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2021
• 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