MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROSTHESIS

Model Number	DIAMETER 41 mm OFFSET
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number 3014128390-2021-00015.
Event or Problem Description
Patient revised on (b)(6) 2021 due to subscapularis failure approximately 4 months after primary surgery.Surgeon converted anatomic to reverse, explanting the 3-4 peg glenoid size xs, 41x16 offset head, and +0mm double taper; and then implanting components necessary for a reverse configuration (24mm baseplate, +6mm post extension, 36mm eccentric glenosphere with screw, 135/145 36/+3 standard humeral cup, and 4 locking screws).

• Brand Name: HUMERIS
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11804457
• Report Number: 3009532798-2021-00057
• Device Sequence Number: 3098746
• Product Code: HSD
• UDI-Device Identifier: 03701037300473
• UDI-Public: 03701037300473
• 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): 05/07/2021

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: 06/01/2024
• Device Model Number: DIAMETER 41 mm OFFSET
• Device Catalogue Number: 106-4100
• Device Lot Number: N3231
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 05/11/2021
• 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: 50 YR