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

Catalog Number 105-3610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 04/19/2024

Event Type  Injury  

Manufacturer Narrative

The event took place outside the united states ((b)(6)) and was associated with a product that is also cleared for the market in the united states.

Event Description

The patient will be revised due to pain and loosening on (b)(6) 2024.The implantation date was on (b)(6) 2023.

• Brand Name: HUMELOCK REVERSED
• Type of Device: REVERSED SHOULDER PROTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SHOULDER SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: emeric obin ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 19069556
• MDR Text Key: 339675128
• Report Number: 3009532798-2024-00032
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300268
• UDI-Public: 03701037300268
• 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: 04/09/2024

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: 105-3610
• Device Lot Number: U0946
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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