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

Model Number 103-0806

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Failure of Implant (1924); Joint Laxity (4526)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number (b)(4).

Event Description

The patient was revised on (b)(6) 2022 due tot instability.Approximately 8 months after the first surgery.The surgeon explanted 1 centered glenosphere (36), 1 glenoid baseplate (24), 1 humeral cup (36/6), 1 humeral spacer (9), 2 standard screw (20), 1 standard screw (25) and 1 standard screw (30).The surgeon implanted 1 centered glenosphere (40), 1 glenoid baseplate (24), 1 humeral cup (40/6), 1 humeral spacer (9), 1 standard screw (20), 2 standard screw (25) and 1 standard screw (30).

• Brand Name: HUMELOCK REVERSED
• Type of Device: REVERSED SHOULDER PROSTHESIS
• 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: 14486804
• MDR Text Key: 292479160
• Report Number: 3009532798-2022-00109
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300107
• UDI-Public: 03701037300107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 103-0806
• Device Catalogue Number: 103-0806
• Device Lot Number: P0983
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2022
• 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