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

Model Number 314-0034

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2022

Event Type  Injury  

Event Description

The patient was revised on (b)(6) 2022 due to dismantling.Approximately 35 days after the first surgery.The surgeon explanted 1 2 pegs glenoid, 1 centered head, 1 double taper and 1 anchor base.The surgeon implanted 1 humeral cup ø36+9, 1 glenoid baseplate, 1 centered glenosphere with screw, 3 locking screw and 1 humelock stem.

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.

• Brand Name: EASYTECH ANATOMIQUE
• Type of Device: UNCEMENTED PROSTHESIS SHOULDER
• 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: 14216738
• MDR Text Key: 290145652
• Report Number: 3009532798-2022-00108
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 03701037301470
• UDI-Public: 03701037301470
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 314-0034
• Device Catalogue Number: 314-0034
• Device Lot Number: S0823
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/27/2022
• 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