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

Model Number	105-0024
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised on (b)(6) 2022 due to a infection.Approximately 237 days after the first surgery.The surgeon explanted stem 32/10, ø 36+3 cup, centered glenosphere, two locking screw, two standard screw and glenoid baseplate.The surgeon implanted two cortical screw, two locking screw, two standard screw, eccentric glenosphere, ø40+9 cup, glenoid baseplate and ø 36/12 stem.
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.
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
Patient was revised on (b)(6) 2022 due to a infection.Approximately 237 days after the first surgery.The surgeon explanted stem 32/10, ø 36+3 cup, centered glenosphere, two locking screw, two standard screw and glenoid baseplate.The surgeon implanted two cortical screw, two locking screw, two standard screw, eccentric glenosphere, ø40+9 cup, glenoid baseplate and ø 36/12 stem.

• Brand Name: HUMELOCK II REVERSED
• Common Device Name: REVERSED 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: 13469473
• Report Number: 3009532798-2022-00016
• Device Sequence Number: 4128805
• Product Code: PHX
• UDI-Device Identifier: 03701037300237
• UDI-Public: 03701037300237
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2022

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: 03/01/2026
• Device Model Number: 105-0024
• Device Catalogue Number: 105-0024
• Device Lot Number: P1301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/07/2022
• 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