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

Model Number	107-4524
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2022
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 on (b)(6) 2022 due to fracture.Approximately 4 years and 1 month after the first surgery.The surgeon explanted 2 cortical screws lg 24mm.The surgeon implanted 1 diaphysial plate, 2 locked osteosynthesis screw, 1 standard screw, 2 locking screw.

• Brand Name: HUMELOCK II REVERSIBLE
• Common Device Name: REVERSIBLE 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: 13937097
• Report Number: 3009532798-2022-00082
• Device Sequence Number: 4013296
• Product Code: HSD
• UDI-Device Identifier: 03701037301951
• UDI-Public: 03701037301951
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/17/2022

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: 11/11/2022
• Device Model Number: 107-4524
• Device Catalogue Number: 107-4524
• Device Lot Number: L2647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/29/2022
• 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