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

Model Number 400-1101

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  Injury  

Event Description

A revision surgery was performed for a conversion from anatomic to reverse configuration due to rotator cuff failure.A size 41 head along with the double cone taper and the glenoid poly were explanted.A 24mm glenoid baseplate, 36 mm glenosphere, 135/145 humeral cup size 36/+ 3, locking screws size 20mm & 30 mm and a standard screw size 30 mm were implanted.

• Brand Name: HUMERIS SHOULDER
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 13095063
• MDR Text Key: 282888440
• Report Number: 3014128390-2021-00070
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037301692
• UDI-Public: 03701037301692
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: 400-1101
• Device Catalogue Number: 400-1101
• Device Lot Number: M0956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2021
• Distributor Facility Aware Date: 12/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female