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

Catalog Number 112-0000

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/01/2021

Event Type  Injury  

Event Description

Patient was revised on (b)(6) 2021 due to patient state, approximately 3 years after the first surgery.The surgeon explanted double taper and bilboquet.The surgeon implanted 135/145 ø36+3 cup, glenoid baseplate, centered glenosphere, two standard screw (l25mm and l20mm) and two locking screw (l30mm and l25mm).

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.

• Brand Name: HUMELOCK II BILBOQUET
• Type of Device: METALLIC UNCEMENTED 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: 13174945
• MDR Text Key: 283315550
• Report Number: 3009532798-2021-00237
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300732
• UDI-Public: 3701037300732
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 112-0000
• Device Lot Number: L2430
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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