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

Catalog Number 312-0703

Device Problem Unstable (1667)

Patient Problem Damage to Ligament(s) (1952)

Event Date 12/06/2022

Event Type  Injury  

Event Description

The patient was revised due to instability on (b)(6) 2022.The implantation date was on (b)(6) 2021.A cup were explanted.A cup were implanted.

Manufacturer Narrative

This mdr has alredy been submitter to fda by the us importer with report number 3014128390-2023-00007.

• 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: 16731591
• MDR Text Key: 313204029
• Report Number: 3009532798-2023-00023
• Device Sequence Number: 1
• Product Code: PHX
• 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: 04/04/2023

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 Catalogue Number: 312-0703
• Device Lot Number: P0324
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2023
• 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