MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK; SHOULDER PROSTHESIS

Model Number	DIAMETER 39 mm CENTERED
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11641750
• Report Number: 3009532798-2021-00042
• Device Sequence Number: 3099436
• Product Code: HSD
• UDI-Device Identifier: 03701037300381
• UDI-Public: 03701037300381
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Model Number: DIAMETER 39 mm CENTERED
• Device Catalogue Number: 106-3914
• Device Lot Number: N0342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention