MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS CEMENTLESS ANATOMIC; PROSTHESIS SHOULDER, HUMERAL

Model Number 106-4800

Device Problems Failure to Osseointegrate (1863); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 09/23/2021

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 rotator cuff failure, approximately 9 months following primary surgery.The surgeon explanted 3-4 pe glenoid size s, size 48 +5 mm centered spacer and 48*9 offset cocr head.The surgeon implanted ø135/145 36/+3 standard humeral cup, 36mm centered glenosphere with screw, 24mm glenoid baseplate and +6mm post extension.

• Brand Name: HUMERIS CEMENTLESS ANATOMIC
• Type of Device: PROSTHESIS SHOULDER, HUMERAL
• 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: 12678959
• MDR Text Key: 277865975
• Report Number: 3009532798-2021-00165
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 106-4800
• Device Catalogue Number: 106-4800
• Device Lot Number: N3232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2019
• 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