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

Model Number	313-0903
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2021, approximately 6 weeks after the primary surgery on (b)(6) 2021 as the humeral cup popped off (disengaged).The humeral cup (36/3) and humeris stem cementless (16) were explanted and a humeral cup (36/3) and humeris stem cementless (18) were implanted.

• Brand Name: HUMERIS REVERSED
• Common Device Name: SHOULDER PROSTHESIS REVERSE
• Manufacturer (Section D): FX SOLUTIONS SAS; 1663 rue de majornas; viriat 01440 ; FR 01440
• MDR Report Key: 13012493
• Report Number: 3014128390-2021-00066
• Device Sequence Number: 5441363
• Product Code: PHX
• UDI-Device Identifier: 03701037310526
• UDI-Public: 03701037310526
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2021
• Report Date (Section F): 12/14/2021

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: 07/01/2026
• Device Model Number: 313-0903
• Device Catalogue Number: 313-0903
• Device Lot Number: S0285
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/14/2021