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

Catalog Number 311-0310

Device Problem Disconnection (1171)

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

Event Date 03/12/2021

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

Patient revised on (b)(6) 2021 due to a dismantling.Ø43 eccentric head, ø10 humeral stem and double tapper were explanted and replaced by ø8 humeral stem, ø36 centered glenosphere, ø36+3 humeral cup and ø24 glenoid baseplate with associated screws.Primary surgery on (b)(6) 2021.

• Brand Name: HUMELOCK II REVERSED
• Type of Device: REVERSED SHOULDER PROTHESIS
• 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: marine le doujet ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11892243
• MDR Text Key: 262192244
• Report Number: 3009532798-2021-00048
• Device Sequence Number: 1
• Product Code: PHX
• 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: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 311-0310
• Device Lot Number: N0822
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2020
• 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