MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS HUMELOCK II; REVERSED SHOULDER PROTHESIS

Catalog Number	311-0212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place outside the united states (in france) and was associated with a product that is also cleared for the market in the united states.
Event or Problem Description
The patient was revised due to a loosening on (b)(6) 2024.The implantation date was on (b)(6) 2023.A cup, a glenosphere, a metaglene and a stem were explanted.An helmet head and a double taper were implanted.

• Brand Name: HUMELOCK II
• Common Device Name: REVERSED SHOULDER PROTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SHOULDER SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: emeric obin ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 19565173
• Report Number: 3009532798-2024-00065
• Device Sequence Number: 12554613
• Product Code: PHX
• UDI-Device Identifier: 03701037301067
• UDI-Public: 03701037301067
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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 Catalogue Number: 311-0212
• Device Lot Number: T2574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Required Intervention
• Patient Sex: Unknown