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

Model Number 400-1101

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

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) 2021 due to rotator cuff failure.Approximately 1 years after first surgery.The surgeon explanted 1 pegs glenoid (xs), 1 offset head cocr (41/16), 1 double taper (0) and 1 humeris stem (08).The surgeon implanted 1 glenoid baseplate (24mm), 1 centered glenosphere (36mm), 1 humeral cup (36/+3), 1 post extension, 2 locking screw and 1 standard screw.

• Brand Name: HUMERUS ANATOMIC
• Type of Device: METALIC 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: 13657940
• MDR Text Key: 286491255
• Report Number: 3009532798-2021-00267
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037301692
• UDI-Public: 03701037301692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/05/2023
• Device Model Number: 400-1101
• Device Catalogue Number: 400-1101
• Device Lot Number: M0956
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2021
• 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