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

Catalog Number 105-3613

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number (b)(4).

Event Description

Patient revised on (b)(6) 2020 approximately 2 years after primary surgery.Surgeon explanted all components except humeral stem (24mm glenoid baseplate, 2 locking screws, 2 standard screws, 36mm eccentric glenosphere with screw, 36/+9 standard humeral cup) and then implanted a 48x19 offset head and 24/10 eccentric taper adapter.

• Brand Name: HUMELOCK REVERSED
• Type of Device: REVERSED SHOULDER PROTHESIS
• 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: cédric joly ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 10534994
• MDR Text Key: 207027756
• Report Number: 3009532798-2020-00427
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150488
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 105-3613
• Device Lot Number: K489
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2017
• 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: 67 YR