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

Model Number	316-0012
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised due to an infection on (b)(6) 2022.The implantation date was on (b)(6) 2022.A cup, a glenosphere and a stem were explanted.No implant was implanted.
Additional Manufacturer Narrative
The event took place outside the united stated (in (b)(6) and was associated with a product that is also cleared for the market in the united states.

• Brand Name: HUMERIS REVERSED
• 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: 16214312
• Report Number: 3009532798-2023-00006
• Device Sequence Number: 14566194
• Product Code: PHX
• UDI-Device Identifier: 03701037301579
• UDI-Public: 03701037301579
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/19/2023

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 Expiration Date: 05/01/2026
• Device Model Number: 316-0012
• Device Catalogue Number: 316-0012
• Device Lot Number: P1984
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/20/2023
• 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