MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOUDLER PROTHESIS

Catalog Number 105-3613

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Code Available (3191)

Event Date 12/18/2019

Event Type  Injury  

Event Description

Surgery was delayed for an additional four hours.Surgeon decision to switch from anatomic to reverse after bending peripheral pegs on glenoid.Difficulty engaging baseplate with 36 eccentric glenosphere with screw.Difficulty with 36 centered glenosphere with screw and size 12 stem and 36/+3 humeral cup, due to stem spinning out when reduced.Tried size 16 stem and 36/+6 humeral cup, but continued to dislocate after reduction.Size 18 stem, reversed adapter for +9mm, 40/+3 humeral cup, and 40 eccentric glenosphere with screw implanted successfully.

• Brand Name: HUMERIS
• Type of Device: SHOUDLER PROTHESIS
• 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: 9824300
• MDR Text Key: 188257966
• Report Number: 3009532798-2020-00010
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2020

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 Expiration Date: 03/01/2023
• Device Catalogue Number: 105-3613
• Device Lot Number: L2569
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• 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: 59 YR