MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK; SHOULDER PROSTHESIS

Model Number DIAMETER 39 mm CENTERED

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2021

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 a failure of the rotator cuff approximately 5 months after the primary surgery.The primary surgery used the easytech anatomical system, the revision surgery is using the humelock reversed system.The surgeon explanted the +0 double taper, the xs anatomical glenoid, the ø39 centered head and the ø34 anchor base.He implanted a cemented metaphysis ø32 stem, a ø24 baseplate, a ø36 centered glenosphere, ø36 humeral cup, a 10mm post extension and associated screws.

• Brand Name: HUMELOCK
• 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: 11641750
• MDR Text Key: 244662762
• Report Number: 3009532798-2021-00042
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300381
• UDI-Public: 03701037300381
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111097
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIAMETER 39 mm CENTERED
• Device Catalogue Number: 106-3914
• Device Lot Number: N0342
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• 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