MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROSTHESIS

Catalog Number 106-4300

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Skin Tears (2516)

Event Date 01/21/2021

Event Type  Injury  

Event Description

Patient revised on (b)(6) 2021, following a dislocation which caused a tear in the rotator cuff.Surgeon converted total anatomic to a reverse; explanting the size s 3-4 peg glenoid, 43x17 offset cocr head, and +0mm double taper; then implanting 135/145 36/+6 stability cup, 35mm centered glenosphere with screw, 24mm baseplate with central screw, and 4 locking screws.

• Brand Name: HUMERIS
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11259786
• MDR Text Key: 229672962
• Report Number: 3014128390-2021-00001
• Device Sequence Number: 1
• Product Code: HSD
• 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: 02/01/2021

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: 106-4300
• Device Lot Number: L1734
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2021
• Distributor Facility Aware Date: 01/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR