MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK 2; REVERSED SHOULDER PROTHESIS

Model Number 105-3610

Device Problem Unstable (1667)

Patient Problems Damage to Ligament(s) (1952); Subluxation (4525)

Event Date 12/29/2022

Event Type  Injury  

Event Description

The patient was revised due to dislocation on (b)(6) 2022.The implantation date was on (b)(6) 2022.A cementless glenoid baseplate and a glenosphere were explanted.A cementless glenoid baseplate and a glenospher were implanted.

Manufacturer Narrative

This mdr has already been submitter to fda by the us importer with report number 3014128390-2023-00004.

• Brand Name: HUMELOCK 2
• 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: ratsamy thevenin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 16731289
• MDR Text Key: 313200035
• Report Number: 3009532798-2023-00018
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 105-3610
• Device Catalogue Number: 105-3610
• Device Lot Number: T1087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2023
• 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): Hospitalization