MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROSTHESIS

Model Number DIAMETER 41 mm OFFSET

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

This was initially reported by our importer under mdr 3014128390-2021-00002.

Event Description

Patient revised on (b)(6) 2021 due to continued pain following the primary surgery on (b)(6) 2020.Surgeon converted the 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
• 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: 11363980
• MDR Text Key: 233031923
• Report Number: 3009532798-2021-00020
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300473
• UDI-Public: 03701037300473
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIAMETER 41 mm OFFSET
• Device Catalogue Number: 106-4100
• Device Lot Number: N2139
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• 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: 51 YR