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

Model Number DIAMETER 48 mm OFFSET

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number (b)(4).

Event 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
• Type of Device: UNCEMENTED 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: ludovic badey ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12188099
• MDR Text Key: 262192033
• Report Number: 3009532798-2021-00101
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300503
• UDI-Public: 03701037300503
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: DIAMETER 48 mm OFFSET
• Device Catalogue Number: 106-4800
• Device Lot Number: N3232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR