MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROSTHESIS

Catalog Number 105-3610

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 10/09/2019

Event Type  Injury  

Event Description

A patient required revision surgery on (b)(6) 2019, after their glenosphere disassociated from the baseplate.The primary surgery was about 18 months prior (exact surgery date unknown).During the revision the surgeon explanted all glenoid components, including a 36mm centered glenosphere with screw and a 24mm glenoid baseplate, as well as the 36/+3 135/145 humeral cup.The surgeon replaced the humeral cup with a larger 36/+9 135/145 humeral cup and implanted new glenoid components from a different manufacturer.

• Brand Name: HUMERIS
• Type of Device: 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: samantha sterling ; 13465 midway rd; suite 101; dallas, TX 75244 ; 2148904109
• MDR Report Key: 9240965
• MDR Text Key: 173997839
• Report Number: 3014128390-2019-00042
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163669
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 105-3610
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 70 YR