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

Model Number Size 12 Cementless

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The event was a revision surgery due to postop fracture (due to trauma) that occured approximately 2 months after the primary surgery.The primar surgery used the anatomical humelock ii system.During the revision surgery, the surgeon explanted all the components : the +0 double taper, the size 12 cementless stem, the 39x15 offset head, a cortical screw and smartloops.

• Brand Name: HUMELOCK II
• 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: 11796989
• MDR Text Key: 249713176
• Report Number: 3009532798-2021-00056
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037301067
• UDI-Public: 03701037301067
• 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
• 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 Model Number: Size 12 Cementless
• Device Catalogue Number: 311-0212
• Device Lot Number: P1534
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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