MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS CEMENTLESS ANATOMICAL; UNCEMENTED SHOULDER PROSTHESIS

Model Number	DIAMETER 48 mm OFFSET
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number (b)(4).
Event or Problem Description
Patient revised on (b)(6) 2021 due to continued pain following primary surgery on (b)(6) 2020.Surgeon converted anatomic to a reverse, explanting all components except stem (3-4 peg glenoid size l, 48x19 offset cocr head, +0mm double taper) and then implanting 24mm cementless glenoid baseplate, +6mm post extension, 40mm centered glenosphere with screw, 135/145 40/+3 standard humeral cup, and 4 screws.

• Brand Name: HUMERIS CEMENTLESS ANATOMICAL
• Common Device Name: UNCEMENTED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12188099
• Report Number: 3009532798-2021-00101
• Device Sequence Number: 17207250
• Product Code: HSD
• UDI-Device Identifier: 03701037300503
• UDI-Public: 03701037300503
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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: 09/01/2025
• Device Model Number: DIAMETER 48 mm OFFSET
• Device Catalogue Number: 106-4800
• Device Lot Number: N3232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 07/19/2021
• 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: 63 YR