MAUDE Adverse Event Report: FX SOLUTIONS HUMÉRIS ANATOMIQUE; UNCEMENTED SHOULDER PROSTHESIS

Model Number 106-3914

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.

Event Description

The patient was revised on (b)(6) 2022 due to unknown reason.Approximately 1 day after the last surgery.The surgeon explanted 1 double taper and 1 centered head 39.The surgeon implanted 1 eccentric head 43 and 1 centered spacer ø43+3mm.

• Brand Name: HUMÉRIS ANATOMIQUE
• Type of Device: UNCEMENTED 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: 13937813
• MDR Text Key: 288093486
• Report Number: 3009532798-2022-00079
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300381
• UDI-Public: 03701037300381
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/01/2023
• Device Model Number: 106-3914
• Device Catalogue Number: 106-3914
• Device Lot Number: M1813
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2022
• 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