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

Catalog Number 311-0312

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Damage (2104)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery due to a cuff tear occurred (b)(6) 2019.Cemented humeral stem and centered head were removed and replaced by cemented humeral stem, glenoid baseplate, glenosphere and humeral cup.Primary surgery occurred in 2018 (exact date unavailable).

• Brand Name: HUMELOCK II
• Type of Device: 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: 9859065
• MDR Text Key: 184264560
• Report Number: 3009532798-2020-19252
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Catalogue Number: 311-0312
• Device Lot Number: J124
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2015
• 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