MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS CEMENTLESS; SHOULDER PROSTHESIS

Catalog Number 316-0012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2020

Event Type  Injury  

Event Description

Patient revised on (b)(6) 2020 approximately 18 months after primary surgery (prompted by a gunshot wound).Surgeon explanted entire anatomic construct (size 12 cementless humeris stem, 46x17 centered head, +0mm double taper, and 3-4 peg glenoid size l).He then replaced it with a reversed construct (size 10 cementless humelock ii stem, 24mm glenoid baseplate, 135/145 40/+6 standard humeral cup, 40mm centered glenosphere with screw, +10mm post extension, and 4 locking screws).

• Brand Name: HUMERIS CEMENTLESS
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11064749
• MDR Text Key: 223388784
• Report Number: 3014128390-2020-00089
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 316-0012
• Device Lot Number: M1844
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2020
• Distributor Facility Aware Date: 12/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2020
• 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: 34 YR