MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROSTHESIS

Catalog Number 106-4100

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 01/21/2021

Event Type  Injury  

Event Description

Patient revised on (b)(6) 2021 due to continued pain following primary surgery on (b)(6) 2020.Surgeon converted total anatomic to a reverse; explanting the size s 3-4 peg glenoid, 41x16 offset cocr head, and +0mm double taper; and then implanting 135/145 36/+3 standard humeral cup, 24mm glenoid baseplate, 36mm centered glenosphere with screw, +6mm post extension, 1 locking screw, and 4 standard 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: 11259824
• MDR Text Key: 229666836
• Report Number: 3014128390-2021-00002
• 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 Catalogue Number: 106-4100
• Device Lot Number: N2139
• 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: 01/21/2021
• 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: 51 YR