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

Model Number	105-4010
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/28/2021
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 patient was revised for infection on (b)(6) 2021.Approximately 2 months after the first surgery.The surgeon explanted 1 humelock stem, 1 centered glenosphere with screw, 1 humeral cup ø40+9, 1 glenoid baseplate, 1 post extension, 1 standard screw l25mm, 1 standard screw l35mm and 2 locking screw.The surgeon implanted 1 post extension, 1 glenoid baseplate, 2 locking screw, 2 standard screw, 1 eccentric glenosphere with screw, 1 humelock stem, 2 cortical screw and 1 humeral cup 135/145° ø40+9.

• 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: 13415776
• Report Number: 3009532798-2021-00268
• Device Sequence Number: 5893710
• Product Code: HSD
• UDI-Device Identifier: 03701037300305
• UDI-Public: 03701037300305
• 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: 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): 02/01/2022

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: 01/06/2026
• Device Model Number: 105-4010
• Device Catalogue Number: 105-4010
• Device Lot Number: P1594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 02/01/2022
• 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