MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROSTHESIS

Model Number DIAMETER 43 mm OFFSET

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

This was initially reported by our importer under mdr 3014128390-2021-00001.

Event Description

Patient revised on (b)(6) 2021, following a dislocation which caused a tear in the rotator cuff.Surgeon converted total ananatomic to a reverse ; explanting the size s 3-4 peg glenoid, 43x17 offset cocr head, and +0mm double taper ; then implanting 135/145 36/+6 stability cup, 35mm centered glenosphere with screw, 24 mm baseplate with central screw, and 4 locking screws.This was initially reported by our importer under mdr 3014128390-2021-00001.

• Brand Name: HUMERIS
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: cedric joly ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11342777
• MDR Text Key: 233812467
• Report Number: 3009532798-2021-00001
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300480
• UDI-Public: 03701037300480
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: DIAMETER 43 mm OFFSET
• Device Catalogue Number: 106-4300
• Device Lot Number: L1734
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2018
• 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
• Patient Age: 57 YR