MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERSED; REVERSED SHOULDER PROSTHESIS

Model Number	316-0012
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	12/14/2021
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
Patient was revised on (b)(6) 2021 due to a allergy, the same day of the first surgery.The surgeon explanted humeris stem ta6v size 12, centered glenosphere and 135/145 ° ø36+3 cup.The surgeon implanted humeris stem ta6v size 12, centered glenosphere cocr tin and 135/145 ° ø36+3 cup.

• Brand Name: HUMELOCK REVERSED
• 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: 13235858
• Report Number: 3009532798-2021-00255
• Device Sequence Number: 4547234
• Product Code: PHX
• UDI-Device Identifier: 03701037301579
• UDI-Public: 03701037301579
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163669
• 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: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2022

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 Expiration Date: 10/01/2026
• Device Model Number: 316-0012
• Device Catalogue Number: 316-0012
• Device Lot Number: S0460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/12/2022
• 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