MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK II; REVERSED SHOULDER PROTHESIS

Catalog Number 106-4300

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Implant Pain (4561)

Event Date 12/18/2023

Event Type  Injury  

Event Description

The patient was revised for reduced mobility on (b)(6) 2023, resulting from the deterioration of the rotator cuff following non-compliance with installation techniques (ascension of the stem not locked by the operator).The implantation date was on (b)(6) 2023.An offset head and a double taper were explanted.A cup, a glenosphere, a metaglene and screws were implanted.

Manufacturer Narrative

The event took place outside the united states (in france) and was associated with a product that is also cleared for the market in the united states.

• Brand Name: HUMELOCK II
• Type of Device: REVERSED SHOULDER PROTHESIS
• 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: emeric obin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 18370729
• MDR Text Key: 331047447
• Report Number: 3009532798-2023-00129
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300480
• UDI-Public: 03701037300480
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2023

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 Operator: Health Professional
• Device Catalogue Number: 106-4300
• Device Lot Number: N0409
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/21/2023
• 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): Required Intervention; Hospitalization