MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS REVERSIBLE; REVERSIBLE SHOULDER PROSTHESIS

Model Number	313-0703
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/17/2022
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 dislocation.Approximately 13 days after the first surgery.The surgeon explanted 1 humeral cup 135/145° ø36+3.The surgeon implanted 1 humeral cup 135/145° stability ø40+9.

• Brand Name: HUMERIS 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: 13937594
• Report Number: 3009532798-2022-00072
• Device Sequence Number: 17144655
• Product Code: PHX
• UDI-Device Identifier: 03701037301357
• UDI-Public: 03701037301357
• 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: 2022
• 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): 03/10/2022

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 Model Number: 313-0703
• Device Catalogue Number: 313-0703
• Device Lot Number: S1241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• 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