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

Model Number	UNIQUE SIZE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place outside of the united states ((b)(6)) and was associated with a product that is also cleared for the market within the united states.
Event or Problem Description
The event was a revision surgery due to loosening that occured approximately 2 months after the primary surgery.The primar surgery used the humeris reversed system.The surgeon explained the loosening of the baseplate was coming from a too high bone graft that made it unstable.The surgeon explanted the ø24 baseplate and the 10mm post extension and they were replaced by the same products.He explanted the ø36/+3 135/145 humeral cup and replaced it by a ø40/+3 135/145 humeral cup.He explanted also the ø36 centered glenosphere and replaced it by a ø40 centered glenosphere.He also explanted associated scews.

• Brand Name: HUMERIS REVERSED
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11892142
• Report Number: 3009532798-2021-00060
• Device Sequence Number: 3686011
• Product Code: PHX
• UDI-Device Identifier: 03701037300237
• UDI-Public: 03701037300237
• 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 Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2025
• Device Model Number: UNIQUE SIZE
• Device Catalogue Number: 105-0024
• Device Lot Number: P1305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 05/27/2021
• 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: Required Intervention