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

Model Number 314-0042

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2022

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 to state patient.Approximately 1 year and 7 months after the first surgery.The surgeon explanted 1 centered spacer (46/5), 1 3-4 pegs glenoid (m), 1 centered head (46x17) and 1 anchor base (42).The surgeon implanted 1 glenoid baseplate (24), 1 centered glenosphere (36), 1 stem (36/12), 1 humeral spacer (9), 1 humeral cup (36/3), 2 locking screws (15), 2 standard screws (30) and 1 central screw (20).

• Brand Name: EASYTECH ANATOMIC
• 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: 13899702
• MDR Text Key: 287886536
• Report Number: 3009532798-2022-00059
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 03701037313732
• UDI-Public: 03701037313732
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/22/2022

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: 314-0042
• Device Catalogue Number: 314-0042
• Device Lot Number: P1202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/25/2022
• 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