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

Model Number 316-0016

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2021

Event Type  Injury  

Event Description

The patient was revised on (b)(6) 2021 due to failure in the repair of the rotator cuff.The patient was initially implanted with humeris anatomical which was then revised to reverse configuration.A humeris stem cementless (16), double taper, 3-4 pegs glenoid and cocr head (50x20) were explanted.A glenoid baseplate (24), centered glenosphere (40/10) and post extension cementless (6) were implanted.

Event Description

The patient was revised on (b)(6) 2021 due to failure in the repair of the rotator cuff.The patient was initially implanted with humeris anatomical which was then revised to reverse configuration.A double taper, 3-4 pegs glenoid and cocr head (50x20) were explanted.A glenoid baseplate (24), centered glenosphere (40/10), post extension cementless (6), humeral cup (40/3), 2 standard screws (25 mm and 35 mm each) and 2 locking screws ( 20 mm and 25 mm each) 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: 13122151
• MDR Text Key: 283077959
• Report Number: 3014128390-2021-00073
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037303689
• UDI-Public: 03701037303689
• 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,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 316-0016
• Device Catalogue Number: 106-5000
• Device Lot Number: M1826
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male