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

Catalog Number	112-0000
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem 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).
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.

• Brand Name: HUMELOCK II BILBOQUET
• Common Device Name: 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
• Report Number: 3009532798-2021-00237
• Device Sequence Number: 4653799
• Product Code: HSD
• UDI-Device Identifier: 03701037300732
• UDI-Public: 3701037300732
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2021

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 Expiration Date: 01/01/2023
• Device Catalogue Number: 112-0000
• Device Lot Number: L2430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown