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

Catalog Number 311-0508

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.

Event Description

Revision surgery occurred (b)(6) 2019, 5 days after the primary surgery.During the post-operative x-ray, they saw that the stem was coming out of the bone.The size 8 humeral stem and the ø36/+3 humeral cup were removed and replaced by same size humeral steam and the ø36/+3 humeral cup.

• Brand Name: HUMELOCK II
• 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: cedric joly ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 9811438
• MDR Text Key: 183386111
• Report Number: 3009532798-2020-19422
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2024
• Device Catalogue Number: 311-0508
• Device Lot Number: N0724
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• 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