MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK II ANATOMIQUE; SHOULDER PROSTHESIS

Catalog Number 311-0210

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Anatomic humelock ii extraction (stem, offset head, double taper and cortical srew) for functional failure of the prosthesis due to rotator cuff rupture.The surgeon sets up a prosthesis from a concurrent lab.

• Brand Name: HUMELOCK II ANATOMIQUE
• 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: cedric joly ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11523495
• MDR Text Key: 240963392
• Report Number: 3009532798-2021-00039
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: 311-0210
• Device Lot Number: M2689
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2018
• 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