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

Catalog Number 105-3610

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 04/09/2019

Event Type  Injury  

Event Description

Revision of reverse shoulder occurred.The revision was necessitated due to the disassociation of the glenosphere approximately 6 weeks after the primary surgery.The glenosphere and pe liner were explanted.According to the surgeon, it was "a bony osteophyte superior to the baseplate preventing it from seating.".

• Brand Name: HUMERIS SHOULDER
• 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: 8666502
• MDR Text Key: 146921051
• Report Number: 3014128390-2019-00010
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/30/2019

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 Catalogue Number: 105-3610
• Device Lot Number: M2334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 68 YR