MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERSED; REVERSED SHOULDER PROSTHESIS

Model Number HUMERAL SPACER TA6V +9 mm

Device Problem Material Separation (1562)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number 3014128390-2021-00042.

Event Description

Patient revised on (b)(6) 2021 due to humeral spacer disassociating from humeral stem.Components implanted on (b)(6) 2021.Surgeon explanted 36/+9 stability humeral cup and +9mm humeral spacer, and then implanted a new 36/+9 stability humeral cup and new +9mm humeral spacer.

• Brand Name: HUMELOCK REVERSED
• Type of Device: REVERSED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: ludovic badey ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12405798
• MDR Text Key: 269305485
• Report Number: 3009532798-2021-00129
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300084
• UDI-Public: 03701037300084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/18/2021

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 Model Number: HUMERAL SPACER TA6V +9 mm
• Device Catalogue Number: 103-0007
• Device Lot Number: P0258
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• 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: 66 YR