MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS ANATOMIC; REVERSED SHOULDER PROSTHESIS

Catalog Number	112-0000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place outside the united states (in france) and was associated with a product that is also cleared for the market in the united states.
Event or Problem Description
The patient was revised (b)(6) 2022 after the primary surgery on 2018 due to loosening.A head and a double cone were explanted.A glenosphere, 3 screws, a metaglene, a cup and a taper were implanted.

• Brand Name: HUMERIS ANATOMIC
• 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: 15786694
• Report Number: 3009532798-2022-00131
• Device Sequence Number: 14889960
• Product Code: PHX
• UDI-Device Identifier: 03701037300732
• UDI-Public: 3701037300732
• 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 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): 11/09/2022

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 Catalogue Number: 112-0000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/14/2022
• 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