MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROSTHESIS

Catalog Number 106-4100

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 03/25/2021

Event Type  Injury  

Event Description

Patient revised on (b)(6) 2021 due to subscpuaris failure approximately 4 months after primary surgery.Surgeon converted anatomic to a reverse, explanting the 3-4peg glenoid sze xs, 41x16 offset head, and +0mm doube taper; and then implanting components necessary for a reverse configuration (24mm baseplate, +6mm post extension, 36mm eccentric glenosphere with screw, 135/145 36/+3 standard humeral cup, 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: 11660771
• MDR Text Key: 245325310
• Report Number: 3014128390-2021-00015
• 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: 04/13/2021

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: 06/01/2024
• Device Catalogue Number: 106-4100
• Device Lot Number: N3231
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2021
• Distributor Facility Aware Date: 03/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2021
• 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: 50 YR