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

Catalog Number 104-1006

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

Patient Problem Joint Laxity (4526)

Event Date 03/27/2024

Event Type  Injury  

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.

Event Description

The patient was revised due to dismantling on (b)(6) 2024.The implantation date was on (b)(6) 2022.A cup and a glenosphere were explanted.A cup and a glenosphere were implanted.

• 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: 19031609
• MDR Text Key: 339230305
• Report Number: 3009532798-2024-00031
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037309452
• UDI-Public: 03701037309452
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 104-1006
• Device Lot Number: T1005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2024
• 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): Required Intervention; Hospitalization