MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROSTHESIS

Model Number DIAMETER 41 mm OFFSET

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number 3014128390-2021-00015.

Event Description

Patient revised on (b)(6) 2021 due to subscapularis failure approximately 4 months after primary surgery.Surgeon converted anatomic to reverse, explanting the 3-4 peg glenoid size xs, 41x16 offset head, and +0mm double taper; and then implanting components necessary for a reverse configuration (24mm baseplate, +6mm post extension, 36mm eccentric glenosphere with screw, 135/145 36/+3 standard humeral cup, and 4 locking screws).

• Brand Name: HUMERIS
• Type of Device: 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: 11804457
• MDR Text Key: 250059286
• Report Number: 3009532798-2021-00057
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300473
• UDI-Public: 03701037300473
• 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
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/07/2021

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: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: DIAMETER 41 mm OFFSET
• Device Catalogue Number: 106-4100
• Device Lot Number: N3231
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2020
• 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; Required Intervention
• Patient Age: 50 YR