MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; REVERSED SHOULDER PROTHESIS

Model Number	314-0906
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised due to loosening on (b)(6) 2023.The implantation date was on (b)(6) 2023.A cup was explanted.A cup was implanted.
Additional Manufacturer Narrative
This mdr has alredy been submitter to fda by the us importer with report number 3014128390-2023-00012.

• Brand Name: HUMERIS
• Common Device Name: REVERSED SHOULDER PROTHESIS
• 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: 16909544
• Report Number: 3009532798-2023-00031
• Device Sequence Number: 15316410
• Product Code: PHX
• UDI-Device Identifier: 03701037310502
• UDI-Public: 03701037310502
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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 Model Number: 314-0906
• Device Catalogue Number: 314-0906
• Device Lot Number: P2033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 05/11/2023
• 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