MAUDE Adverse Event Report: FX SOLUTIONS EASYTECH ANATOMIC; ANATOMIC SHOULDER PROSTHESIS

Model Number 314-0038

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/15/2021

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

Patient was revised on (b)(6) 2021 due to infection.Approximately three weeks after the first surgery.The surgeon explanted anchor base, centered head, 2 pegs glenoid and double taper.The surgeon implanted the same implant (anchor base, centered head, 2 pegs glenoid and double taper).

• Brand Name: EASYTECH ANATOMIC
• Type of Device: ANATOMIC 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: 12679492
• MDR Text Key: 277857642
• Report Number: 3009532798-2021-00154
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 03701037301487
• UDI-Public: 03701037301487
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/18/2021

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 Operator: No Information
• Device Model Number: 314-0038
• Device Catalogue Number: 314-0038
• Device Lot Number: S0089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/22/2021
• 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