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

Catalog Number 106-3900

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number 3014128390-2020-00073.

Event Description

Patient revised on october 1 2020, approximately 15 months after primary surgery.Surgeon converted total to a reverse due to failure of the rotator cuff.Surgeon explanted all components except stem (39x15 offset head, +0mm double taper, 3-4 peg glenoid size xs) and then implanted a 135/145 36/+3 standard humeral cup, 36mm centered glenosphere with screw, 24mm glenoid baseplate, and three standard screws.

• Brand Name: HUMERIS
• Type of Device: UNCEMENTED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: cedric joly ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 10690410
• MDR Text Key: 211703678
• Report Number: 3009532798-2020-00481
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111097
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: 106-3900
• Device Lot Number: L1757
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2018
• 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: 66 YR