MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS ANATOMIC; CEMENTED SHOULDER PROSTHESIS

Model Number 105-0004

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 03/07/2022

Event Type  Injury  

Event Description

The patient was revised on (b)(6) 2022 due to instability.Approximately 5 months after the last surgery.The surgeon explanted 1 double taper (0), 1 2 pegs glenoid (l) and 1 offset head (50x20).The surgeon implanted 1 glenoid baseplate (24), 1 central screw (12), 2 standard screw (25), 2 locking screw (20, 15), 1 centered glenosphere (40) and 1 humeral cup (40/3).

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number (b)(4).

• Brand Name: HUMERIS ANATOMIC
• Type of Device: CEMENTED 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: 13993200
• MDR Text Key: 288469785
• Report Number: 3009532798-2022-00077
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 03701037300190
• UDI-Public: 03701037300190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/06/2023
• Device Model Number: 105-0004
• Device Catalogue Number: 105-0004
• Device Lot Number: M2015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2022
• 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