MAUDE Adverse Event Report: FX SOLUTIONS ANATOMICAL HUMERIS; SHOULDER PROSTHESIS

Model Number HUMERIS STEM TA6V SIZE 08 CEMENTLESS Ti/HA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Impotence (1925)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

The event took place outside of usa ((b)(6)) and was associated with a product that is also cleared for the market within the usa.

Event Description

Removal of an anatomical humeris placed many years ago because of significant glenoiditis and functional impotence of the patient.This day, a reversed humelock 2 is placed.

• Brand Name: ANATOMICAL HUMERIS
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des marjonas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue des marjonas; viriat, 01440 ; FR 01440
• Manufacturer Contact: cedric joly ; 1663 rue des marjonas; viriat, 01440 ; FR 01440
• MDR Report Key: 11342644
• MDR Text Key: 232356838
• Report Number: 3009532798-2021-00016
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037301531
• UDI-Public: 03701037301531
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K163669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2021

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: 06/01/2023
• Device Model Number: HUMERIS STEM TA6V SIZE 08 CEMENTLESS Ti/HA
• Device Catalogue Number: 316-0008
• Device Lot Number: M1752
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• 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